Drug recall D-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
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.
Lots and codes
a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
Recall details
- Recalling firm
- Boehringer Ingelheim Roxane Inc, Columbus, OH
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 2, 2015
- Terminated
- February 19, 2016
Related products
- Acarbose – drug information
- NDC 0054-0142 Acarbose · Acarbose 100 mg/1 · Hikma Pharmaceuticals USA Inc.
- NDC 0054-0140 Acarbose · Acarbose 25 mg/1 · Hikma Pharmaceuticals USA Inc.
- NDC 0054-0141 Acarbose · Acarbose 50 mg/1 · Hikma Pharmaceuticals USA Inc.