D-0352-2020 Class II
FDA drug recall D-0352-2020 was initiated by Altaire Pharmaceuticals, Inc. on July 2, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility Affected quantity: 1737549 containers.
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
- 1737549 containers
Product Description
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: RGC, Exp 7/19; RHB, RHC, Exp 8/19; RID, RIC, RIG, Exp 9/19; RKH, RKI, RKJ, RKK, RKL, Exp 11/19; RLM, Exp 12/19; SAI, Exp 1/20; SBG, SBH, Exp 2/20; SCF, Exp 3/20, SEA, Exp 5/20; SFA, SFB, Exp 6/20; SHA, Exp 8/20; SIB, Exp 9/20; SJC, Exp 10/20; TAB, TAF, Exp 1/21; TBP, TBQ, Exp 2/21; TCV, TCW, Exp 3/21