Boehringer Ingelheim Roxane Inc recalls Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 count Bottles, Rx only, Roxane Laboratories,

Recalled June 3, 2015 · FDA recall D-1085-2015 · Boehringer Ingelheim Roxane

Hazard

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point. · FDA Class II

Units

a) 575 Blister Packs, b) 12,802 Bottles

Sold at

Nationwide and Puerto Rico

Description

Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.

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

Manufacturer(s)

Boehringer Ingelheim Roxane Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →