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Recall Observatory FDA recall evidence

Drug product

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

D-0732-2021

July 29, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88442
Status
Terminated
Classification
Class II
Quantity
16,226 vials
Official record key
drug-enforcement:D-0732-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: a) 31327056B, exp. date 03/2022; 31328547B, exp. date 01/2023; b) 31327066B, exp. date 03/2022

Distribution pattern: Product was distributed Nationwide, including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility