FDA recall D-1085-2015

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Completed

Initiation date

2015-04-02

Report date

2015-06-03

Termination date

2016-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1085-2015