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Recall Observatory FDA recall evidence

Drug product

Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03

D-0375-2021

April 26, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 87875
Status
Terminated
Classification
Class II
Quantity
3150 vials
Official record key
drug-enforcement:D-0375-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # 31325793C, exp. date 09/2021

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility