D-1178-2017 Class II Terminated

Recalled by Teva Pharmaceuticals USA — North Wales, PA

FDA drug recall D-1178-2017 was initiated by Teva Pharmaceuticals USA on September 5, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 21, 2018). Affected quantity: 3,275 bottles.

Recall Details

Product Type
Drugs
Report Date
October 4, 2017
Initiation Date
September 5, 2017
Termination Date
June 21, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,275 bottles

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 1082710A, Exp 07/18