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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 1082710A, Exp 07/18
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1178-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Oct 4, 2017
- Quantity
- 3,275 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1178-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78060
- Address
- 1090 Horsham Rd
- Code information
- Lot #: 1082710A, Exp 07/18
- Postal code
- 19454-1505
- Report date
- Oct 4, 2017
- Product type
- Drugs
- Recall number
- D-1178-2017
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 3,275 bottles
- Termination date
- Jun 21, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 28, 2017