Drug 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
D-1085-2015
Product summary
- Event
- Event 70990
- Status
- Completed
- Classification
- Class II
- Quantity
- a) 575 Blister Packs, b) 12,802 Bottles
- Official record key
drug-enforcement:D-1085-2015
Official wording
Reason: Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Code information: a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent