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Recall Observatory FDA recall evidence

Drug product

Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Perrigo Minneapolis, MN 55427 NDC 0574-4250-35

D-0353-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
121572 containers
Official record key
drug-enforcement:D-0353-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: SAC, Exp 1/20; SLK, Exp 12/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility