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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
January 20, 1999

PRODUCT
Various drug products:
a) Lidocaine HCl Injection, 2%, 50 ml
      NDC   0402-0056-50   (Steris Laboratories)
      NDC   0364-6551-57   (Schein Pharmaceutical)
      NDC   0839-5598-38   (Moore Medical)
      NDC   0456-0782-83   (Forest Pharmaceuticals)
      NDC   55553-056-50   (Clint Pharmaceuticals)
      NDC   52384-011-50   (Teregen Labs)
      NDC   66467-1460-0   (Darby Group (Carlisle))
b) Orphenadrine Citrate Injection, 30 mg/ml, 10 ml
      NDC   0402-0129-10   (Steris Laboratories)
      NDC   0364-6747-54   (Schein Pharmaceutical)
      NDC   0456-1092-10   (Forest Pharmaceutical)
      NDC   58238-301-10   (Deliz Pharmaceuticals)
      NDC   55553-129-10   (Clint Pharmaceuticals)
c) Trimethobenzamide HCl Injection, 100 mg/ml, 20 ml
      NDC   0402-0164-20   (Steris Laboratories)
      NDC   0364-6762-55   (Schein Laboratories)
d) Hydroxyzine HCl Injection, 50 mg/ml, 10 ml
      NDC   0402-0171-10   (Steris)
      NDC   0364-6719-54   (Schein Pharmaceutical)
      NDC   0839-6338-30   (Moore Medical)
      NDC   0182-1182-63   (Goldline Laboratories)
      NDC   0536-5060-70   (Rugby Laboratories)
      NDC   66467-5060-1   (Darby Group (Carlisle))
      NDC   55553-171-11   (Clint Pharmaceuticals)
e) Bacteriostatic Sodium Chloride Injection, 0.9%, 30 ml
      NDC   0402-0191-30   (Steris Laboratories)
      NDC   0364-6559-56   (Schein Pharmaceutical)
      NDC   0839-5628-36   (Moore Medical)
      NDC   0536-2501-75   (Rugby Laboratories)
f) Betamethasone Sodium Phosphate Injection 4 mg/ml, 5 ml
      NDC   0402-0217-05   (Steris Laboratories)
      NDC   0364-6751-53   (Schein Pharmaceutical)
      NDC   66467-3544-8   (Darby Group (Carlisle))
      NDC   0785-9060-05   (UAD Laboratories)
g) Dexpanthenol Injection, 250 mg/ml, 30 ml
      NDC   0402-0260-30   (Steris Laboratories)
      NDC   30727-316-80   (Merit Pharmaceuticals)
      NDC   49072-161-30   (McGuff Company)
h) Gentamicin Sulfate Injection, 40 mg/ml, 2 ml
      NDC   0402-0559-02   (Steris Laboratories)
      NDC   0364-6739-48   (Schein Pharmaceuticals)
      NDC   0839-6503-23   (Moore Medical)
      NDC   0182-1424-61   (Goldline Laboratories)
      NDC   0536-4690-67   (Rugby Laboratories)
      NDC   66467-4685-9   (Darby Group (Carlisle))
I)  Hydroxyprogesterone Caproate Injection, 250 mg/ml, 5 ml
      NDC   0402-0598-05   (Steris Laboratories)
      NDC   0364-6690-53   (Schein Pharmaceutical)
      NDC   52047-598-05   (Wintec, Inc.)
j) Brompheniramine Maleate Injection, 10 mg/ml, 10 ml
      NDC   0402-0602-10   (Steris Laboratories)
      NDC   0364-2185-54   (Schein Pharmaceutical)
      NDC   45985-629-10   (Stewart Jackson Pharmaceutical)
      NDC   0456-0623-10   (Forest Pharmaceuticals)
      NDC   55553-602-10   (Clint Pharmaceuticals)
      NDC   0314-2237-70   (Hyrex Pharmaceuticals)
k) Levothyroxine Sodium 500 mcg Vial
      NDC   0402-0732-10   (Steris Laboratories)
      NDC   0364-6772-54   (Schein Pharmaceutical)
l) Levothyroxine Sodium 200 mcg Vial
      NDC   0364-2248-54   (Steris Laboratories)
m) Dexamethasone Sodium Phosphate Ophthalmic Solution, 0.1%, 5 ml
      NDC   0402-0748-05   (Steris Laboratories)
      NDC   0364-7237-53   (Schein Pharmaceuticals)
      NDC   0839-6663-25   (Moore Medical)
      NDC   0677-0898-20   (United Research Laboratories)
      NDC   0536-0800-65   (Rugby Laboratories)
      NDC   11695-4188-1   (Butler Company)
      DIN   00785261        (Pharmascience, Inc.)
      DIN   02023865        (Dioptic Laboratories)
n) Gentamicin Sulfate Ophthalmic Solution, 0.3%, 5 ml
      NDC   0402-0749-05   (Steris Laboratories)
      NDC   0364-7388-53   (Schein Pharmaceuticals)
      NDC   0839-6745-25   (Moore Medical)
      NDC   0168-0248-03   (E. Fougera)
      NDC   66467-0925-8   (Darby Group (Carlisle))
      NDC   0814-3448-38   (IDE-Interstate)
      DIN   02219581        (Schein Pharmaceutical Canada)
   Gentamicin Sulfate Ophthalmic Solution, 0.3%, 15 ml
      NDC   0402-0749-15   (Steris Laboratories)
o) Neomycin-Dexamethasone Sodium Phosphate Ophthalmic Solution,
   5 ml
      NDC   0402-0775-05   (Steris Laboratories)
      NDC   0364-0762-53   (Schein Pharmaceuticals)
      NDC   0168-0249-03   (E. Fougera)
p) Pilocarpine HCl Ophthalmic Solution, 4%, 15 ml
      NDC   0402-0866-15   (Steris Laboratories)
      NDC   0364-7134-72   (Schein Pharmaceuticals)
      DIN   02229395        (Technilab, Inc. Canada)
q) Doxapram Injection, 20 ml
      NDC   0402-0954-20   (Steris Laboratories)
r) Bacteriostatic Water for Injection, 30 ml
      NDC   0402-1057-30   (Steris Laboratories)  
      NDC   66647-2611-3   (Darby Group (Carlisle))
      NDC   0182-0741-66   (Goldline Laboratories)
      NDC   0839-5180-36   (Moore Medical)
      NDC   0677-1546-23   (United Research Laboratories)
      NDC   0536-2620-75   (Rugby Laboratories).
Recall #D-073/090-9.

CODE
Lot numbers: a) 97F130, 97A410; b) 96A200, 96B070, 97B300, 97F900; c) 96D020, 97D260; d) 96E740; e) 97C580; f) 97B700; g) 97M220; h) 97B550, 97G240; I) 97H370; j) 96L950, 97F080, 97L020; k) 96J050, 97C360; l) 95K770, 95K830, 96C310, 96C970, 96D910, 96L050, 96L100, 97B640, 97C630; m) 97B940, 97H850; n) 96M580, 96N240, 96N241, 96N530, 96N531, 97A900, 97A901, 96L580; o) 97A710, 97H320; p) 97B401; q) 98A510; r) 96E170.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on November 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 41,158 vials; b) 121,372; c) 45,848 vials; d) 72,729 vials; e) 30,923 vials; f) 78,126 vials; g) 21,913 vials; h) 208,910 vials; I) 26,609 vials; j) 48,329 vials; k) 28,794 vials; l) 107,590 vials; m) 69,710 bottles; n) 290,567 5 ml-bottles and 21,620 15-ml vials; o) 119,418 vials; p) 28,874 bottles; q) 1,950 vials; r) 27,792 vials were distributed.

REASON
Current good manufacturing practice deviations: Lack of complete process validation.

 

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.