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Recall Observatory FDA recall evidence

Drug product

Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

D-0463-2022

December 21, 2021

Class II

Product summary

Firm
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Event
Event 89270
Status
Ongoing
Classification
Class II
Quantity
57,994 vials
Official record key
drug-enforcement:D-0463-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry

Distribution pattern: nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility