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,…

Recall date

April 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1085-2015

FDA classification

Class II

Brand / firm

Boehringer Ingelheim Roxane Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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