|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 3, 1998
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.
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.
Steris Laboratories, Inc., Phoenix, Arizona
Manufacturer, by letter on March 18, 1998. Firm-initiated recall ongoing.
Nationwide and Puerto Rico.
2,230,007 bottles were distributed; firm estimated that 16,000 bottles
remained on the market at time of recall initiation.
Stability - Lack of data at labeled storage conditions.