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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 3, 1998

PRODUCT
a) Amoxicillin for Oral Suspension, USP, 125 mg per 5 mL, 80, 100 and 150 ml when mixed, Rx semisynthetic antibiotic, 125 mg/5 mL, NDC #55953-149-38, -40, -47, also packaged under the Major label, Distributed by Major Pharmaceuticals, Livonia, MI, NDC #0904-2619-04, -07 and Qualitest label, Distributed by Qualitest Pharmaceuticals, Inc. Huntsville, AL, NDC #0603-6500-64, -66

b) Amoxcillin for Oral Suspension, USP, 250 mg per 5 mL, 80, 100 and 150 mL when mixed, 250 mg/5 mL, NDC #55953-130-38, -40, -47, also packaged under the Major label, NDC #0904-2620-04, -07, Rx antibiotic.

Recall #D-152/153-8.

CODE
All lots within expiration date.

MANUFACTURER
Novopharm Limited, Scarborough, Ontario, Canada.

RECALLED BY
Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Amount distributed:
a) 28,776 - 80-mL, 96,301 - 100-mL, 203,444 - 150-mL bottles;
b) 40,474 - 80- mL, 246,535 - 100-mL, 970,350 - 150-mL bottles.

REASON
Lack of assurance of homogeneity.

 

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.