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Recall Observatory FDA recall evidence

Drug product

Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10

D-1490-2020

July 22, 2020

Class III

Product summary

Firm
West-Ward Columbus Inc
Event
Event 86079
Status
Terminated
Classification
Class III
Quantity
2300 bottles
Official record key
drug-enforcement:D-1490-2020

Official wording

Reason: Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.

Code information: Lot: #064046A, Exp. 03/2022

Distribution pattern: OH and MS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.