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Recall Observatory FDA recall evidence

Drug product

ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY

D-1251-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
2000 mL in Vials
Official record key
drug-enforcement:D-1251-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 151203-53; BUD: 05/31/16; Lot #: 151217-38; BUD: 06/14/16; Lot #: 160208-36; BUD: 08/06/16

Distribution pattern: U.S. Nationwide, Japan, and New Zealand.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility