October 2017 FDA Recall Bisoprolol Fumarate by Unichem Pharmaceuticals Usa Inc
D-0010-2018 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Unichem Pharmaceuticals Usa Inc on October 2, 2017 for the product Bisoprolol Fumarate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0010-2018

Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Initiated
10-02-2017
Reported
10-25-2017
Quantity
96,876 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78218
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Unichem Pharmaceuticals Usa 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.
Product was distributed nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2018
Product Description About Product Description
Full technical description of the product.
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.

Batch or Lot Expiration Information

Lot# : GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.

Affected Packages Involved in this Recall

29300-126-13 Bisoprolol Fumarate
29300-126-01 Bisoprolol Fumarate
29300-126-05 Bisoprolol Fumarate
29300-127-13 Bisoprolol Fumarate
29300-127-01 Bisoprolol Fumarate
29300-127-05 Bisoprolol Fumarate