Skip to content
Recall Observatory FDA recall evidence

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

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
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

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility