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SafetyAlerts
December 14, 1999

Steris Laboratories, Inc. Recalls Over 5 Million Units of Various Drugs and Medications

Phoenix, AZ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Steris Laboratories is recalling over 5 million units of various human drugs because the company did not have appropriate data to support process validation(s) and defect investigations.

This ongoing Class II recall was initiated by the company, by letter dated October 8, 1999. This is the first notice the FDA has issued to the general public of the recall.

The recalled drugs, distributed nationwide and international, are:

1. Ascorbic Acid Injection, 222 mg/mL, 30 mL vial, 4 lots:
Lot Numbers: 96H760, 97C790, 97G780, 98A070

NDC #30727-645-80 for MERIT PHARMACEUTICALS
2. Ascorbic Acid Injection, 500 mg/mL, 50 mL vial, 4 lots:
NDC #0402-1083-50 for STERIS LABS label
NDC #49072-039-50 for McGUFF COMPANY label
NDC #11694-206-50 for KEY label
Lot Numbers: 98C840, 98D140, 98D360, 98D580

3. Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL vial:
NDC #0402-0191-30 for STERIS LABS label
NDC #0364-6559-56 for SCHEIN PHARMACEUTICAL
NDC #0839-5628-36 for MOORE MEDICAL label
NDC #0536-2501-75 for RUGBY LABORATORIES label
Lot Number: 97C580

4. Bacteriostatic Water for Injection, USP, 30 mL vial:
NDC #0402-1057-30 for STERIS LABS label
NDC #66467-2611-3 for DARBY GROUP label
NDC #0839-5180-36 for MOORE MEDICAL label
NDC #0536-2620-75 for RUGBY LABORATORIES label
Lot Numbers: 96N430, 97D950, 98B530

5. Chorionic Gonadotropin for Injection, USP, 5,000 USP units, Lyophilized With Diluent, 10 mL vial set:
NDC #0402-0125-10 for STERIS LABS label
NDC #57548-125-10 for EVEREADY label
NDC #44087-8005-3 for SERONO LABORATORIES label
Lot Number: 97L910

6. Chorionic Gonadotropin for Injection, USP, 10,000 USP units, Lyophilized With Diluent, 10 mL vial set:
NDC #0402-0126-10 for STERIS LABS label
NDC #0364-6706-54 for SCHEIN PHARMACEUTICAL label
NDC #44087-8010-3 for SERONO LABORATORIES label
NDC #0182-1165-63 for ZENITH-GOLDLINE LABORATORIES label
NDC #99012-126-10 for R. W. ENTERPRISES label
Lot Numbers: 97K710, 98B550, 97J410, 97J510

7. Edetate Disodium Injection, USP, 3g/20 mL (150 mg/mL), 20 mL vial:
NDC #0402-0277-20 for STERIS LABS label
NDC #0364-2485-55 for SCHEIN PHARMACEUTICAL label
NDC #49072-177-20 for McGUFF COMPANY label
NDC #0456-0724-17 for FOREST PHARMACEUTICAL label
NDC #30727-318-65 for MERIT PHARMACEUTICALS label
NDC #11694-720-20 for KEY COMPANY label
Lot Numbers: 96K880, 96F890, 96M330, 96M700, 96N600, 96N750, 97A150, 97A650, 97B010, 97E260, 97E410, 97G060, 97K510, 98B310, 98C050, 98C670, 96N740, 97A510, 97B500

8 & 9. Gentamicin Sulfate Injection, USP, 80 mg/2 mL, 2 mL vial; and Gentamicin Sulfate Injection, USP, 40 mg/mL, 20 mL vial:
NDC #0402-0559-02 for STERIS LABS label [2 ml SIZE]
NDC #0364-6739-48 for SCHEIN PHARMACEUTICAL label [2 ml SIZE]
NDC #66467-4685-9 for DARBY GROUP label [2 ml SIZE]
NDC #0182-1424-61 for ZENITH-GOLDLINE LABORATORIES label
NDC #0536-4690-67 for RUGBY LABORATORIES label [2 ml SIZE]
NDC #0839-6503-23 for MOORE MEDICAL label [2 ml SIZE
NDC #0402-0559-20 for STERIS LABS label [20 ml SIZE]
NDC #0182-1424-65 for ZENITH-GOLDLINE LABORATORIES label [20 ml SIZE]
NDC #66467-4685-2 for DARBY GROUP label [20 ml SIZE]
NDC #0364-6739-55 for SCHEIN PHARMACEUTICAL label [20 ml SIZE]
NDC #0536-4690-73 for RUGBY LABORATORIES label
Lot Numbers:
[for 2 ml SIZES]: 96K870, 97B550, 97G240
[for 20 ml SIZES]: 97A570, 97C210, 97G290

10. Metoprolol Tartrate Injection, USP, 5 mg/5mL, 5 mL vial:
NDC #0364-3036-25 for SCHEIN PHARMACEUTICAL label
Lot Numbers: 97J300, 97J350, 97J360, 97J590, 97K470, 97L290, 97M320, 98A910, 98B570, 98C250, 98C890, 98D150, 98D380, 98E120, 98D740, 98E530, 98F150

11. Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP, 1 mL Ampul:
NDC #0364-2190-41 for SCHEIN PHARMACEUTICAL label
Lot Numbers: 96L260, 97B320, 97B910, 97F160, 97F220, 97J110, 97J320, 98A350, 98A830, 98B190

12. Phenylephrine Hydrochloride Ophthalmic Solution, USP, 10%, 5 mL dropper bottle:
NDC #0402-0799-05 for STERIS LABS label
NDC #0364-2370-53 for SCHEIN PHARMACEUTICAL label
NDC #51394-226-10 for WILSON OPHTHALMICS label
NDC #54799-531-05 for OCUSOFT label
Lot Numbers: 96L290, 97C660, 97J100, 97J840, 98D880

13. Vecuronium Bromide for Injection 10 mg, lyophilized powder, 10 mL vial:
NDC #0209-9140-22 for MARSAM PHARMACEUTICAL label
NDC #0209-9140-92 for MARSAM PHARMACEUTICAL label
NDC #0209-9141-26 for MARSAM PHARMACEUTICAL label
Lot Numbers: 98B770, 98C150, 98C270, 98C340, 98C530, 98C700, 98D080, 98D200, 98D250, 98D300, 98D460, 98D621, 98D760, 98E190, 98E350, 98E600, 98E880, 98F010, 98F090, 98F180

14. Vecuronium Bromide for Injection 20 mg, lyophilized powder, 20 mL vial:
NDC #0209-9143-22 for MARSAM PHARMACEUTICAL label
NDC #0209-9143-92 for MARSAM PHARMACEUTICAL label.
Lot Numbers: 98B780, 98C390, 98D110, 98D260, 98D770, 98E220, 98E640

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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