Bisoprolol Fumarate Tablet
FDA Recall NDC 29300-127
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bisoprolol Fumarate (NDC 29300-127). A significant event, classified as Class II, was initiated on Oct 02, 2017 by Unichem Pharmaceuticals (usa), Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2017 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Oct 02, 2017
Oct 25, 2017
96,876 bottles
Recall Profile & Regulatory Data
Event ID
78218
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Unichem Pharmaceuticals Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide
Termination Date
Sep 13, 2018
Product Description
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
29300-126-13Product
29300-126-01Product
29300-126-05Product
29300-127-13Product
29300-127-01Product
29300-127-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
