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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

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

PRODUCT
Neomycin and Polymyxin B Sulfate and Hydrocortisone Otic Solution, USP (Neomycin sulfate, equivalent To 3.5 mg Neomycin base/Polymyxin B Sulfate 10,000 units/Hydrocortisone 10 mg), 10 mL bottles of 30, used for otic use only, under the following labels: Schein Pharmaceutical, Steris Laboratories Inc., Akorn, Carlisle, Erva, Fougera, Geneva, Generics of Puerto Rico, Goldline, IDE, H. L. Moore, Major, Marlop Pharmaceuticals Inc., Mason, Parmed, Robar Inc., Rugby, Teral, Teva, and United Research Laboratories.

Recall #D-149-8.

CODE
95C960, 95C961, 95D370, 95D371, 95D420, 95D620, 95D950, 95D951, 95D970, 95E040, 95E260, 95E410, 95E790, 95E990, 95F380, 95F570, 95G200, 95G450, 95G830, 95H020, 95H021, 95H640, 95H880, 95H881, 95J070, 95J120, 95L240, 95L820, 96A360, 96A490.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona

RECALLED BY
Manufacturer, by letter on March 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
2,230,007 bottles were distributed; firm estimated that 16,000 bottles remained on the market at time of recall initiation.

REASON
Stability - Lack of data at labeled storage conditions.

 

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.