D-0358-2020 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
195,864 unts

Product Description

Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (NDC 0574-4025-35), Manufactured for Perrigo, Minneapolis, MN 55427

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot #: RJH, Exp 10/19; SCC, Exp 3/21; SGA, Exp 7/21; SGH, Exp 7/21; SHH, Exp 8/21; SLL, Exp 12/21; TAC, Exp 1/22