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
Product summary
- 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
Labeling: Incorrect or Missing