D-0355-2020 Class II

Recalled by Altaire Pharmaceuticals, Inc. — Aquebogue, NY

Recall Details

Product Type
Drugs
Report Date
November 27, 2019
Initiation Date
July 2, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
261,528 units

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

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