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Recall Observatory FDA recall evidence

Drug product

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01

D-0737-2021

July 29, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88442
Status
Terminated
Classification
Class II
Quantity
434,229 vials
Official record key
drug-enforcement:D-0737-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 31325852B, 31325985B, exp. date 10/2021; 31326349B, exp. date 01/2022; 31326873B, exp. date 03/2022; 31326995B, exp. date 05/2022 31327158B, exp. date 06/2022; 31328946B, 31329180B, exp. date 05/2023.

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