April 2015 FDA Recall Acarbose by Boehringer Ingelheim Roxane Inc
D-1085-2015 - Subpotent Drug

This Class II drug recall was voluntarily initiated by Boehringer Ingelheim Roxane Inc on April 2, 2015 for the product Acarbose. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-1085-2015

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.
Initiated
04-02-2015
Reported
06-03-2015
Quantity
a) 575 Blister Packs, b) 12,802 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70990
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2016
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# a)
Lot# 460073A Exp 04/2016 b)
Lot# 460073B Exp 04/2016

Affected Packages Involved in this Recall

0054-0140-25 Acarbose
0054-0141-20 Acarbose
0054-0141-25 Acarbose
0054-0142-25 Acarbose