Why it was recalled
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Product description
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
Lot numbers, UPCs & expiration codes
a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
Where it was sold
Nationwide and Puerto Rico
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-1085-2015
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Apr 2, 2015
- FDA report date
- Jun 3, 2015
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Boehringer Ingelheim Roxane Inc
Original FDA data
Every field from FDA enforcement report D-1085-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Completed
- Country
- United States
- Event ID
- 70990
- Address
- 1809 Wilson Rd
- Code information
- a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
- Postal code
- 43228-9579
- Report date
- Jun 3, 2015
- Product type
- Drugs
- Recall number
- D-1085-2015
- Classification
- Class II
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- Product quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Termination date
- Feb 19, 2016
- Reason for recall
- Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC a) 0054-0141-20, b) 0054-0141-25
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 2, 2015
- Initial firm notification
- Letter
- Center classification date
- May 27, 2015