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Recall Observatory FDA recall evidence

Drug product

Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.

D-1178-2017

September 05, 2017

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 78060
Status
Terminated
Classification
Class II
Quantity
3,275 bottles
Official record key
drug-enforcement:D-1178-2017

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.

Code information: Lot #: 1082710A, Exp 07/18

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing