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Recall Observatory FDA recall evidence

Drug product

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

D-1285-2015

June 23, 2015

Class III

Product summary

Firm
Actavis Laboratories, FL, Inc.
Event
Event 71755
Status
Terminated
Classification
Class III
Quantity
11,445 Bottles
Official record key
drug-enforcement:D-1285-2015

Official wording

Reason: Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Code information: Lot # 982021M, Expiry: DEC. 2016

Distribution pattern: U.S. Nationwide including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.