Drug product
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Net. Wt. 3.5 g (1/8 oz.), Rx only, Manufactured for Perrigo, Minneapolis, MN 55427, NDC 0574-4021-35
D-0355-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 261,528 units
- Official record key
drug-enforcement:D-0355-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: RGD, Exp 7/19; RHL, Exp 8/19; RHB, Exp 9/19; RJF, Exp 10/19; RJG, Exp 10/19; SAJ, Exp 1/20; SAK, Exp 1/20; SAL, Exp 1/20; SAM, Exp 1/20; SBK, Exp 2/20; SEH, Exp 5/20; TCD, Exp 1/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility