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SafetyAlerts
February 7, 2003

Schering Corp Has Recalled Drugs

 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
a) Garamycin Ophthalmic Ointment, USP (Gentamicin Sulfate)
0.3%, 3.5g tube, Rx only. Recall # D-069-3;
b) Celestone Phosphate Injection, USP(Betamethasone sodium
phosphate) 3 mg/mL, 5mL Multiple-Dose Vial, Rx only,
NDC-0085-0879-05. Recall # D-070-3;
c) Solganal Injectable Suspension , USP(Aurothioglucose),
500 mg, 50 mg/mL, 10 mL Multiple-Dose Vial, Rx only,
NDC-0085-0460-03. Recall # D-071-3;
d) Trilafon Injection, USP (Perphenazine), 5 mg, 1 mL
Ampule, NDC-0085-0012-04, Rx only. Recall # D-072-3;
e) Sterile Diluent (Bacteriostatic Water for Injection with
benzyl alcohol 0.945% w/v), 1 mL, NDC-0009-0780-46, Rx
only. Recall # D-073-3;
f) Bacteriostatic Water for Injection, USP., 2 mL syringe.
Recall # D-074-3.

CODE
a) All lots within expiry: 0-HJ-1, March 2003; 0-HG-2,
March 2003.
b) All lots within expiry: 0-AKP-3, August 2003; 0-AKP-2,
June 2003; 0-AKP-1, May 2003. 0-AKP-4, September 2003.
c) All lots within expiry: 0-WS-4, November 2002; 0-WS-5,
December 2002; 1-WS-1, March 2003.
d) All lots within expiry: 1-AEC-1, April 2004; 1-AEC-2,
April 2004; 9-AEC-9, November 2002.
e) All lots within expiry: 0-BEX-501, Mar-21-2003; 0-BEX-
502, Mar-25-2003; 0-BEX-503, Apr-02-2003; 0-BEX-504,
Apr-26-2003; 0-BEX-505, Jun-27-2003; 0-BEX-506, Jul-12-
2003; 0-BEX-507, Jul-12-2003; 0-BEX-508, Nov-18-2003;
0-BEX-509, Dec-01-2003; 0-BEX-510, Dec-27-2003; 1-BEX-
501, Feb-11-2004; 1-BEX-502, Feb-12-2004; 1-BEX-503,
Feb-22-2004; 1-BEX-505, Mar-22-2004; 1-BEX-506, Mar-29-
2004; 1-BEX-507, May-28-2004; 1-BEX-508, May-29-2004;
1-BEX-509, May-30-2004; 1-BEX-511, Aug-15-2004; 1-BEX-
512, Aug-20-2004; 1-BEX-513, Aug-27-2004; 1-BEX-514,
Aug-30-2004; 1-BEX-515, Oct-29-2004; 1-BEX-517, Nov-14-
2004.
f) All lots within expiry: 1-BEX-701, Mar-2003; 1-BEX-702,
Dec-2003; 2-BEX-701, Jan-14-2004.

RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ, by letter dated November 8, 2002. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility.

VOLUME OF PRODUCT IN COMMERCE
4,047,706 units.

DISTRIBUTION
Nationwide and Caribbean islands: Bahamas, Curacao, Trinidad, Jamaica, St. Kitts and Aruba.

 

 
Selected Recent Recalls


Health Professional:

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

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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.