Class II
Completed
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
- Company
- Boehringer Ingelheim Roxane Inc
- Recall Initiated
- April 2, 2015
- Posted
- June 3, 2015
- Recall Number
- D-1085-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Firm Location
- Columbus, OH, United States
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
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