Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 167
Summary
The FDA issued a Class III for Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-003 by Zydus Pharmaceuticals (USA) Inc. Reason: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substa.
Details
Source
Drug Recall
External ID
D-0467-2023
Action Date
2023-03-22
Status
Terminated
Category
drug
Product Description
Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Lot/Code Info: Lot #s: a) E203821, Exp. 05/2024; b) E203822, Exp. 05/2024, E206186, Exp. 10/2024; c) E203820, Exp. 05/2024.
Quantity Affected: 21,936/30 count bottles and 33,096/100 count bottles
Reason for Recall
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Distribution
AZ, OH, MS.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
Company
Pennington, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0467-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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