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.
Recall initiated: 20150402
Status: Completed
Classification: Class II
Recall type: Voluntary: Firm initiated