Recall: D-1085-2015

Class II - Potentially Harmful

Class IIClassification

2015-04-02Initiated

CompletedStatus

Boehringer Ingelheim Roxane InFirm

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

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

Distribution

Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.