Recalls / Class II
Class IID-1085-2015
Product
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
- Brand name
- Acarbose
- Generic name
- Acarbose
- Active ingredient
- Acarbose
- Route
- Oral
- NDCs
- 0054-0140, 0054-0141, 0054-0142
- FDA application
- ANDA078470
- Affected lot / code info
- a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
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.
Recalling firm
- Firm
- Boehringer Ingelheim Roxane Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, Columbus, Ohio 43228-9579
Distribution
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-04-02
- FDA classified
- 2015-05-27
- Posted by FDA
- 2015-06-03
- Terminated
- 2016-02-19
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1085-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.