Recalls / Class II
Class IID-1178-2017
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.
- Affected lot / code info
- Lot #: 1082710A, Exp 07/18
Why it was recalled
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 3,275 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-05
- FDA classified
- 2017-09-28
- Posted by FDA
- 2017-10-04
- Terminated
- 2018-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1178-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.