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Safety Alerts
August 25, 1999

93 Different Injections and Solutions From Steris Laboratories Recalled

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories is recalling Apetonil Jarabe because of a lack of sufficient data from an adequately validated laboratory test method to assure products meet all regulatory requirments, including but not limited to methods validation and potency.

PRODUCT
93 Different Injections and Solutions From Steris Laboratories:
1. AntiliriumÆ Injection (Physostigmine salicylate), 1 mg/mL, 2 mL ampules, under the Forest label
2. Artificial Tears Plus - Lubricant, Ophthalmic Solution, (Polyvinyl Alcohol 1.4%) 15 mL bottle, under the following labels: Steris, Rugby, Schein, Canada
3. Artificial Tears- Lubricant, Ophthalmic Solution, (Polyvinyl Alcohol 1.4%) 15 and 30 mL bottles, under the following labels: Steris, Scein, AARP Pharmacy Service
4. Ascorbic Acid Injection, (Preserved) 222 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, McGuff, Merit
5. Atropine Sulfate Opthalmic Solution, USP, 1%, 15 mL bottle, under the following labels: Steris, Schein, The Butler Company
6. Vitamin B Complex 100 Injection (Thiamine Hydrochloride 100 mg), 30 mL multiple dose vials, under the following labels: Steris, Merit, McGuff, Darby Group, Hyrex, Key Company
7. Betamethasone Sodium Phosphate Injection, USP 4 mg/mL (equiv. to Betamethasone 3 mg/mL), 5 mL vials, under the following labels: Steris, Schein, Darby UAD Laboratories
8. Brompheniramine Maleate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Forest, Hyrex, Clint
9. Chlorpheniramine Maleate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the Steris label
10. Cyanocobalamin Injection, USP, 100 mcg/mL, 30 mL Multiple Dose Vials, under the following labels Steris, Moore, Rugby, Goldline
11. Cyanocobalamin Injection, USP, 1000 mcg/mL, 10 and 30 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Carlisle, International Ethical Lab, Major, URL, IDE Interstate, Generics of Puerto Rico, Keene, Darby, Sorter Laboratories, Clint, Cytex, Schein Canada, Taro, Key Company, McGuff, Merz, San Jose Surgical, Martin Surgical, Besse, Forest, Wesley, Merit, Robar, CO Truxton, Legere, Stewart Jackson
12. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension, USP), 16 mg/mL, 1 and 5 mL vials, under the Forest label
13. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension, USP), 8 mg/mL, 5 mL vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Major, URL, AF Hauser, Keene, Darby, Clint, Insource, Allied Pharmaceutical Group, Merz Pharmaceuticals, San Jose Surgical, Martin Surgical Supply, Besse Medical, Forest, Teregen Labs, Radford Therapeutics, Robar, Legere Pharmaceuticals, Stewart Jackson
14. Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 5 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Ace Surgical Supply, Clint, RW Enterprise, Merz Pharmaceuticals, Forest Pharmaceuticals, Teregen Labs, Legere, Cytex, Taro
15. Dexamethasone Sodium Phosphate Injection, USP, 10 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Clint, Robar
16. Dexamethasone Sodium Phosphate (Ophthalmic Solution, USP), 0.1% , 5 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, Moore, Rugby, URL, Butler, Darby, Akorn, E Fougera, Pharmascience, Dioptic Laboratories
17. Dexpanthenol Injection, 250 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, McGuff, Merit
18. Diazepam Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Darby, Goldline, URL, Ace Surgical Supply, Western Medical Supply
19. Dicyclomine Hydrochloride Injection, USP, 10 mg/ml, 10 mL Multiple Dose Vial, under the Schein label
20. Dicyclomine Hydrochloride Injection, USP, 20 mg / 2mL, 2 mL vial, under the Steris and Schein labels
21. Dimenhydrinate Injection, USP, 50 mg/mL, 1 and 10 mL vials, under the Steris and Schein labels
22. Diphenhydramine HCL Injection, USP, 50 mg/mL, 10 mL Multiple Dose Vials, under the following labels: Steris, Schein, Moore, Goldline, Schein Canada, Pharmascience
23. Diphenhydramine HCL Injection, USP, 10 mg/mL, 30 mL Multiple Dose Vials, under the Steris, Schein, Darby labels
24. Dobutamine Injection, USP, 250 mg/20mL, 20 mL Single Dose Vial, under the Schein label
25. Doxapram Hydrochloride Injection, USP, 20 mg/mL, 20 mL Multiple Dose Vials, under the Steris and Schein labels
26. Estradiol Cypionate Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Darby, Goldline, Forest, Clint
27. Estradiol Valerate Injection, USP, 20 mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, Flint labels
28. Estradiol Valerate Injection, USP, 40 mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, Clint labels
29. Gentamicin Sulfate, Ophthalmic Solution, USP, 0.3%, 5 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, Darby, Moore, E Fougera, Schein Canada, Technilab
30. Garatec-Gentamicin Sulfate OTIC Drops, 0.3%, 5 mL Bottle, under the Technilab label
31. Heparin Sodium Injection, USP, 5,000 Units/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, URL labels
32. Heparin Sodium Injection, USP, 10,000 Units/mL, 10 mL Multiple Dose Vial, Under the Steris, Schein, Rugby labels
33. Hydrocortisone Acetate Suspension, USP, (for injection), 25 mg/mL, 10 mL vial, under the Steris, Schein, URL, Darby labels
34. Hydromorphone HCL Injection, USP, 10 mg/mL, 1 mL ampul, under the Marsam Pharmaceutical label
35. Hydromorphone HCL Injection, USP, 50 mg/5mL, 5 mL ampul, under the Marsam Pharmaceutical label
36. Hydroxyprogesterone Caproate Injection, USP, 250 mg/mL, 5 mL Multiple dose vial, under the following labels: Steris, Schein, Rugby, Hyrex, Wintec
37. Hydroxyzine Hydrochloride Injection, USP, 25 mg/mL, 10mL Multiple Dose Vial, under the Steris and Schein labels
38. Hydroxyzine Hydrochloride Injection, USP, 50 mg/mL, 10mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Darby, Clint
39. Levothyroxine Sodium for Injection, lyophilized, 200 mcg/vial, single dose vial, under the Schein label
40. Levothyroxine Sodium for Injection, lyophilized, 500 mcg/vial, single dose vial, under the Steris and Schein labels
41. Lidocaine Hydrochloride Injection, USP, 1%, 50 mL, Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, Darby, Clint, Forest, Teregen Labs, URL
42. Lidocaine Hydrochloride Injection, USP, 2%, 50 mL, Multiple Dose Vial, Steris, Schein, Moore, Goldline, Darby, Clint, Forest, Teregen
43. Lincomycin Hydrochloride Injection, USP, 300 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Moore, Goldline, Darby, Clint, Llorens, Keene, Besse, Radford Therapeutics, Martin Surgical Supply
44. Lorazepam Injection, USP, 2 mg/mL, 1 and 10 mL vials, under the Marsam label
45. Lorazepam Injection, USP, 4mg/mL, 10 mL vial, under the Marsam label
46. Meperidine Hydrochloride Injection, USP, 300 mg/30mL, 30 mL Single Dose Vial, under the Schein label
47. Meperidine Hydrochloride Injection, USP, 50 mg/mL, 30 mL Multiple Dose Vial, under the Steris and Schein labels
48. Meperidine Hydrochloride Injection, USP, 100 mg/mL, 20 mL Multiple Dose Vial, under the Steris and Schein labels
49. Mepivacaine Hydrochloride Injection, USP, 1%, (10 mg/mL), 50 mL Multiple Dose Vial, under the Steris and Schein labels
50. Mepivacaine Hydrochloride Injection, USP, 2%, (20 mg/mL), 50 mL Multiple Dose Vial, under the Steris and Schein labels
51. Methylprednisolone Acetate Injection Suspension, USP, 20 mg/mL, 10 mL Multiple Dose Vial, under the Steris and Radford labels
52. Methylprednisolone Acetate Injection Suspension, USP, 40 mg/mL, 5 and 10 mL Multiple Dose Vial, Steris, Schein, Moore, Goldline, URL, Clint, San Jose Surgical, Besse, Forest, A&G Pharmaceuticals, Radford Therapeutics, Merz Pharmaceutical, Stewart Jackson Pharmaceutical, Darby Group
53. Methylprednisolone Acetate Injection Suspension, USP, 80 mg/mL, 5 mL Multiple Dose Vial, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Hyrex, Keene, Clint, Merz, San Jose Surgical, Besse, Forest, Radford, Legere, Stewart Jackson
54. Methocarbamol Injection, USP, 100 mg/mL, 10 mL Single Dose Vial, under the following labels: Steris, Schein, Univet Pharm, Pharmascience, Brock Vet Supply
55. Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple Dose Vial, under the Steris and Schein labels
56. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC Solution, USP, 10 mL Sterile bottle with Sterilized Dropper, under the following labels: Steris, Schein, Moore, Parmed, Darby, Teva, E Fougera, Robar, Generics of Puerto Rico, Teral Labs, Erva Pharmaceuticals, Pedinol Pharmaceutical, Akorn, Marlop, URL
57. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC Suspension, USP, 10 mL Sterile bottle with Sterilized Dropper, under the following labels: Steris, Schein, Moore, Rugby, Goldline, UAD Labs, E Fougera, Generics of Puerto Rico, Teral Labs, URL, Akorn
58. Neomycin and Polymyxin B Sulfates Solution For Irrigation, USP, 20 mL Multiple Dose Vial, under the Schein label
59. Neomycin Sulfate and Desamethasone Sodium Phosphate, Ophthalmic Solution, USP, 5 mL Squeeze Dropper Bottle, under the Steris, Schein, E Fougera labels
60. Neostigmine Methylsulfate Injection, USP, 1:2000 (0.5 mg/mL-500 micrograms/mL), 10 mL Multiple Dose Vials, under the Steris and Schein labels
61. Orphenadrine Citrate Injection, USP, 60 mg/2 mL, in 2 mL Ampul, under the following labels: Steris, Schein, International Ethical Lab, Cytex
62. Orphenadrine Citrate Injection, USP, 30 mg/mL, in 10 mL vial, under the following labels: Steris, Schein, Deliz, Clint, Forest
63. Phenylephrine Hydrochloride Injection, USP, 1% (10 mg/mL) 1 mL vial, Single Dose, under the Schein label
64. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 1%, 15 mL Sterile Squeeze Bottle, under the following labels: Steris, Schein, Butler, Schein Canada, Technilab
65. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 2%, 15 mL Sterile Squeeze Bottle, under the following labels: Steris, Butler, Schein Canada, Technilab, Dioptic
66. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 4%, 15 mL Sterile Squeeze Bottle, under the Steris, Schein, Technilab labels
67. Prednisolone Acetate Suspension, USP (Sterile), for intramuscular and intra-articular injection, 25 mg/mL, 30 mL Multiple Dose Vial, under the Steris Schein, and Forest labels
68. Prednisolone Acetate Injectable Suspension, USP (Sterile), for intramuscular and intra-articular injection, 50 mg/mL, 10 and 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, Forest, Darby, Goldline
69. Prednisolone Sodium Phosphate Ophthalmic Solution, USP, 1/8%, 5 mL Squeeze Dropper Bottle, under the Steris, Schein, and Akorn labels
70. Prednisolone Sodium Phosphate Ophthalmic Solution, USP, 1%, 5, 10 & 15 mL Squeeze Dropper Bottles, under the following labels: Steris, Schein, Akorn, E Fougera, Butler
71. Prochlorperazine Edisylate Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial, under the Steris and Schein labels
72. Progesterone Injection, USP, 50 mg/mL, 10 mL Sterile Multiple Dose Vial, under the following labels: Steris, Schein, Moore Rugby, Goldline, Paddock, Eveready, URL, Cytex, Germiphene
73. Pyridoxine Hydrochloride Injection, USP, 100 mg/mL, 10 and 30 mL Multiple Dose Vial, Steris, Schein, McGuff, Merit, Key Company, Legere, Kripps Pharmacy
74. Pentamidine Isethionate for Injection, 300 mg, Lyophilized, Single Dose Vial, under the following labels: Marsam, Pasadena Research Labs
75. Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution, 10% / 0.25%, 5 and 10 mL Squeeze Dropper Bottle, under the following labels: Steris, Schein, E Fougera
76. Sulfacetamide Sodium Ophthalmic Solution, USP, 10 %, 15mL Squeeze Dropper Bottle, under the Forest label
77. SUS-PHRINEÆ (epinephrine 5 mg/mL ) Injectable Suspension, 1:200 , 0.3 mL/Sterile ampul and 5 mL Multiple Dose Vial, under the Forest label
78. Testosterone Cypionate-Estradiol Injection, 50 mg/2mg/mL, 10 mL Multiple Dose Vial, under the Steris, Schein, and Forest labels
79. Testosterone Cypionate Injection, USP, 100 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Goldline, Schein Canada, Cytex
80. Testosterone Cypionate Injection, USP, 200 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Darby, Rugby, Goldline, Star, URL
81. Testosterone Enanthate-Estradiol Valerate Injection, 90 mg/ 4 mg per mL, 10 mL Sterile Multiple Dose Vial, under the Steris and A&G Pharm labels
82. Testosterone Enanthate Injection, USP, 200 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Rugby, Forest, Darby, URL, Pharmascience, Taro
83. Testosterone Injection, USP, 100 mg/mL, 30 mL Multiple Dose Vial, under the following labels: Steris, Schein, Univet, Vetoquinol Canada, Brock Veterinary Supply
84. Testosterone Propionate Injection, USP, 100 mg/mL, 10 mL Multiple Dose Vial, under the following labels: Steris, Schein, Goldline, URL, Cytex, Taro, Germiphene
85. Thiamine Hydrochloride Injection, USP, 100 mg/mL, 30 mL Sterile Multiple Dose Vial, under the Steris, McGuff and Merit labels
86. Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL, Squeeze Dropper Bottle, under the Steris, Schein, and E Fougera labels
87. TacÆ-3 Injectable Suspension (Triamcinolone Acetonide) 3 mg/mL, 5 mL Multi-dose vial, under the Parnell and Allergan labels
88. Triamcinolone Acetonide Injectable Suspension, USP, 40 mg/mL, 1 and 5 mL vials, under the following labels: Steris, Schein, Goldline, RW Enterprise, Schein Canada, Moore, Rugby, URL, Major, Teregen, Clint, Besse, San Jose Surgical, Robar, Forest, Darby, Legere, AF Hauser, CO Truxton, Merz, Cytex
89. Triamcinolone Diacetate Injectable Suspension, USP, 40 mg/mL, 5 mL Multiple Dose vials, under the following labels: Steris, Schein, Moore, Rugby, Goldline, URL, Keene, Carlisle, Clint, Besse, San Jose Surgical, Darby, Forest, Quality Research Pharmaceuticals, Stewart Jackson Pharmaceutical, Hyrex, CO Truxton, Wintec, Mayrand, TaroLegere, Merz, Forest
90. Trifluridine Ophthalmic Solution, 1%, 7.5 mL Squeeze Dropper Bottle, under the Schein label
91. Trimethobenzamide Hydrochloride Injection, USP, 100 mg/mL, 20 mL vial, under the Steris and Schein labels
92. Heparin Sodium Injection, USP, 20,000 Units/mL, 5 mL Multiple Dose vial, under the Steris, Schein, and Rugby labels
93. Nandrolone Decanoate Injection, USP, 50 mg/mL, 2 mL Multiple Dose Vials, under the Steris and Schein labels.

Recall #D-311/403-9.  Class II

CODE
Lot numbers:
1. 96N690, 97F720, 97M430, 98C350
2. 97D180, 97G520, 97J831, 97M300
3. 97A070, 97A730, 97B370, 97B650, 97B660, 97B870, 97C040, 97C681, 97C820, 97D200, 97D300, 97D340, 97D421, 97D430, 97B650, 97B660
4. 96F150, 96L590, 97B290, 97D090, 97J900, 98B800, 98E290
5. 97A520, 97B590, 97G470, 97G680, 97G681
6. 97B890, 97C880, 97C890, 97G530, 98A700, 98A710
7. 97B700
8. 97F080, 97L020
9. 96G970
10. 96F910
11. 96C240, 96F800, 96H640, 96J470, 96N760, 96A080, 97D050, 97D630, 97K240, 97K241, 97M240, 97M241, 96C410, 96E410, 96F160, 96H240, 96H410, 96J070, 96K920, 96L780, 96L940, 96N380, 96N381, 97A060, 97B720, 97C800, 97D220, 97D690, 97F820, 97G310, 97J580, 98A691
12. 97B740, 98C631 ,96B720, 96D110, 96F351, 96L681, 97B741, 97F090, 97M100, 98C630
13. 97A420, 97A930, 97C130, 97C690, 97E190, 97K610, 97L010, 97L140, 97L970, 98A280, 98A890, 98B930
14. 97G281, 97L161, 98E021
15. 97G510
16. 97A260, 97B940, 97H850, 97D280, 97F490, 97F741, 97G750, 97J220, 97J221, 97K930, 97M380, 98A790
17. 97B840, 97M220, 98A180
18. 97B100, 97C910, 97D460, 97D461, 97E130, 97F300, 97H940, 97L310, 98A220, 98A221, 98A900, 98A901, 98B950
19. 97F060 and 97J270
20. 97A160, 97C720, 97G721, 97H890, 97H891, 98A050
21. 97D450, 97H310, 98A020, 98E270, 98E271, 97B970, 97F140
22. 97A660, 97B020, 97B540, 97C180, 97F310, 97F330, 97F331, 97J160,97K100, 97K320, 97K620, 97L380, 98B320, 98D780
23. 97C140 and 97J310
24. 97C400 and 98C810
25. 98A510 and 97C120
26. 96E840, 96G980, 97C230, 97F410, 97L930, 98B200
27. 96J250, 97F101, 97J420
28. 96B410, 96J370, 97M060
29. 97A900, 97A901, 97B310, 97D680, 97E120, 97G440, 97C850
30. 97C850
31. 97E390
32. 97F320 and 97G500
33. 96C120, 96L430, 96N540, 98A210, 98D430
34. 97D790 and 98A090
35. 97A680, 97B130, 97B140, 97C990, 97J170
36. 97M180, 97H370, 96C090
37. 96G920 and 97D410
38. 96E740 and 97B900
39. 96C310, 96C970, 96D910, 96L050, 96L100, 97B640, 97C630
40. 96J050 and 97C360
41. 96A560, 96A980, 96C080, 96C530, 96D050, 96E150, 96G730, 96K270, 96L420, 97B350, 97C840, 97F940
42. 97F130, 97A410, 96B370, 96D180, 96E160, 96J880, 97B610
43. 97A430, 97A690, 97A860, 97C830, 97F460, 97G770, 97J230, 97J550, 97M230, 98C810
44. 97B730, 97C450,97B731
45. 97A380
46. 97A170, 97C050, 97C240, 97D590, 97E210, 97F250, 97F260, 97J950, 97J960, 98B130, 98C010
47. 97G190 and 97J630
48. 97A190
49. 97D970, 97G130, 97H960, 97M280, 98B830
50. 97B260, 97G260, 97K730, 98B870, 98B880, 98D190
51. 97L300 and 97M450
52. 97A590, 97A910, 97F200, 97F201, 97H590, 97J430, 97J540, 97L510, 97B580, 97F420, 97K420, 97K490, 97M140, 98B300
53. 97A810, 97C870, 97H930, 97H931, 97J290, 97L440, 97M030, 98B520, 98B960
54. 97F480
55. 97B9890 and 97D841
56. 96A360, 96A490, 97A090, 97A640, 97A870, 97C030, 97D710, 97D711, 97E030, 97E580, 97E581, 97E590, 97E670, 97E671, 97E920, 97E921, 97F910, 97F911, 97G160, 97G161, 97H050, 97H051, 97H430, 97H431, 97H510, 97H630, 97H631, 97J400, 97J490, 97J910, 97K150, 97K410, 97L130, 97L390, 97M370, 98B400, 98B470, 98B840, 98B910, 98B911, 98C130, 98C320, 98C510, 98C512
57. 97A500, 97A560, 97A580, 97A600, 97A610, 97A700, 97A790, 97A800, 97A960, 97A970, 97B040, 97B050, 97B750, 97B760, 97B761, 97B850, 97B860, 97B920, 97B930, 97C100, 97C110, 97C160, 97C170, 97C920, 97C930, 97D030, 97D040, 97D880, 97D891, 97D930, 97D940, 97E060, 97E070, 97E170, 97E180, 97E240, 97E250, 97E350, 97E351, 97E360, 97E630, 97E640, 97E710, 97E720, 97E730, 97E740, 97E750, 97E751, 97E760, 97E770, 97E780, 97E790, 97E800, 97E810, 97E820, 97F920, 97G030, 97G040, 97G080, 97G090, 97G360, 97G370, 97G860, 97G870, 97G930, 97H080, 97H090, 97H160, 97H410, 97H420, 97H440, 97H450, 97H470, 97H480, 97H540, 97H550, 97H650, 97H660, 97H661, 97H920, 97H921, 97J440, 97J450, 97J790, 97J800, 97J810, 97K010, 97K170, 97K180, 97K220, 97K221, 97K230, 97K300, 97K310, 97L060, 97L070, 97L170, 97L180, 97L181, 97L340, 97L350, 97L420, 97L430, 97M050, 97M150, 98A400, 98A410, 98A730, 98A740, 98A741, 98B220, 98B230, 98B430, 98B440, 98B660, 98B850, 98B851, 98B860, 98C180, 98C190, 98C401, 98C402, 98C410, 98C411, 98C480, 98C550, 98C600, 98C820, 98C821, 98D120, 98D160, 98D170, 98D220, 98D230, 98D320, 98D330, 98D400, 98D410, 98D412, 98D490, 98D491, 98D550, 98D640, 98E160, 98E200, 98E201, 98E330, 98E420
58. 96F420, 96H870, 97C330, 98A360, 98B150
59. 97A710 and 97H320
60. 96D290
61. 96G600, 96H960, 96J940, 97A950, 97D100, 97D650, 97E550, 97E600, 97J080, 97L580, 97M250, 98A290, 98A840, 98C040
62. 96A200, 96B070, 97B300, 97F900
63. 96A870, 96C280, 96D940, 96H990, 96L270, 97B080, 97B800, 97C420, 97E990, 97G760, 97G960, 97H820, 97H910
64. 97D380 and 97K500
65. 97C190
66. 97B401
67. 96D140, 96N290, 97B410, 97D230
68. 96M630, 96B670, 96E260, 96L540, 96M640, 97B490, 97C980, 97L650
69. 97M260
70. 97H330, 97L810, 98A820, 97L740, 97L610, 98A040
71. 97B060, 97B770, 97D210, 97D211, 97E440, 97E450, 97F120, 97F190, 97G850, 97L410, 98A540
72. 97D020, 97F070, 97F450, 97H060, 97H770, 97J120, 98A390, 98B710
73. 97E100, 97E101, 98D890, 97A480, 97F351, 98B280, 98B290
74. 97B520, 97K640, 97L250, 97L520, 98E800, 98A480
75. 97K360, 97K450, 97L840, 97L940, 97L950, 98A880, 97K340, 97L950, 98A960, 98B590
76. 97A980, 97B420, 97C750, 97E230
77. 97M040, 96N400. 97K480, 98B240
78. 97F360
79. 96E830, 96N630, 97K120
80. 96C050, 96F970, 96H930, 96K130, 96M050, 97C900, 97E040, 97F770, 97H530, 97K680, 97K681, 98A130
81. 97F290
82. 96A160, 96H300, 96K320, 96K510, 97E310, 97E490, 97G550, 97G900, 97L030, 98A760, 98B970, 98D390
83. 96J990, 96M040, 97F850, 97J970, 97L150, 97L600, 98B410
84. 96E062, 96K430, 97C760, 97K590, 97L980, 98C460
85. 97B480 and 97C410
86. 97C950, 97F240, 97H300, 97L050, 97L720, 98A860, 98A870
87. 96B600, 97E500, 98A770
88. 97D830, 97D831, 97F830, 97J340, 97K670, 97K160, 98A330, 98B700, 98C370, 98C720, 98D090, 97A250, 97B360, 97D800, 97D810, 97D820, 97F270, 97F831, 97G050, 97J330, 97J341, 97K161, 97K540, 97K671, 97M170, 97M410, 98A331, 98B271, 98B701, 98C200, 98C371, 98C560, 98C721, 98D091, 98D210, 98D470, 98D310
89. 96A640, 96B490, 96C360, 96C470, 96D340, 96E390, 96H050, 96J730, 96M460, 97B830, 97E080, 97F500, 97K660, 98E360, 98B490, 98B940
90. 97C300, 97F030, 97F370, 97F620, 97G340, 97H840, 98A850, 98D240
91. 96D020, 97D260
92. 96D020, 97D260
93. 97F890, 97J620.

MANUFACTURER
Steris Laboratories, Phoenix, Arizona.

RECALLED BY
Manufacturer, by letters on February 19, 1999, and April 1, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITYNumber of vials or units distributed:
1) 230,412 vials;
2) 35,012 vials;
3) 389,970 15-ml bottles and 34,337 30-ml bottles;
4) 159,381 vials;
5) 66,529 bottles;
6) 131,795 vials;
7) 78,126 vials;
8) 32,374 vials;
9) 13,450 vials;
10) 29,990 vials;
11) 1,244,548 10-ml vials and 1,088,261 30-ml vials;
12) 64,210 1-ml and 363,968 5-ml vials;
13) 1,118,536 vials;
14) 97.821 vials;
15) 31,960 vials;
16) 386,874 vials;
17) 10,970 vials;
18) 713,274 vials;
19) 70,527 vials;
20) 569,200 vials;
21) 973,200 1-ml vials and 102,529 10-ml vials;
22) 336,186 vials;
23)48,926 vials;
24) 87,824 vials;
25) 13,068 vials;
26) 210,813 vials; 27) 127,826 vials;
28) 107,441 vials;
29&30) 449,494 vials;
31) 10,018 vials;
32) 17,058 vials;
33) 78,638 vials;
34) 163,090 ampuls;
35) 139,070 ampuls;
36) 96,192 vials;
37) 45,361 vials;
38) 136,607 vials;
39) 82,786 vials;
40) 28,794 vials;
41) 338,345 vials;
42) 173,074 vials;
43) 311,675 vials;
44) 65,512 (1 ml) and 4,901 (10 ml) vials;
45) 1,591 vials;
46) 98,145 vials;
47) 17,775 vials;
48) 8,643 vials;
49) 147,894 vials;
50) 111,133 vials;
51) 33,620 vials;
52) 484,679 (5 ml) and 202,836 (10 ml) vials;
53) 683,697 vials;
54) 94,269 vials;
55) 47,769 vials;
56) 2,811,407 bottles;
57) 5,730,538 bottles;
58) 48,995 vials;
59) 119,418 vials;
60) 6,727 vials;
61) 1,347,045 ampuls;
62) 139,521 vials;
63) 1,685,494 vials;
64) 43,929 vials;
65) 35,018 bottles;
66) 28,874 bottles;
67) 54,170 vials;
68) 16,984 (10 ml) and 83,115 (30 ml) vials;
69) 18,057 bottles;
70) 67,234 (5 ml), 30,933 (10 ml) and 28,277 (15 ml) bottles;
71) 210,270 vials;
72) 534,974 vials;
73) 78,350 (10 ml) and 161,085 (30 ml) vials;
74) 40,581 vials;
75) 167,238 (5 ml) and 68,219 (10 ml) bottles;
76) 141,019 bottles;
77) 188,280 (0.3 ml) and 15,057 (5 ml) vials;
78) 12,619 vials;
79) 115,140 vials;
80) 745,750 vials;
81) 14,773 vials;
82) 409,785 vials;
83) 36,590 vials;
84) 229,098 vials;
85) 34,072 vials;
86) 280,424 bottles;
87) 338,524 vials;
88) 892,567 (1 ml) and 1,568,078 (5 ml) vials;
89) 1,065,376 vials;
90) 142,586 bottles;
91) 45,948 vials;
92) 24,721 vials;
93) 20,740 vials

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.