Drug product
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
D-0352-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 1737549 containers
- Official record key
drug-enforcement:D-0352-2020
Official wording
Reason: Lack of Assurance of Sterility
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
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility