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

FDA recall notice · announced June 3, 2015 · Boehringer Ingelheim Roxane

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: a) Lot # 460073A Exp 04/2016 b) Lot # 460073B Exp 04/2016
Quantity: a) 575 Blister Packs, b) 12,802 Bottles
Status: Completed
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.