FDA Recalls Colchicine Tablets Due to Failed Impurity Specifications
Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving an out-of-specification impurity detected during manufacturing quality control testing. No illnesses or injuries have been reported. Per the severity rubric, FDA Class III recalls are typically scored as 1 or 2; this manufacturing quality issue places it at the Moderate level.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling specific batches of Colchicine Tablets, USP 0.6 mg, a prescription medication used to treat conditions such as gout and familial Mediterranean fever. The recall was initiated because out-of-specification results were observed during release testing for one lot. Specifically, Beta-lumicolchicine, a related substance and degradation impurity, was detected at levels exceeding acceptable manufacturing specifications.
The recalled batches were distributed to Arizona, Ohio, and Mississippi. The recall affects 21,936 bottles of the 30-tablet package size and 33,096 bottles of the 100-tablet package size. Affected lot numbers include E203821, E203822, E206186, and E203820, with expiration dates between May 2024 and October 2024.
No illnesses or injuries have been reported in connection with this recall. Patients currently taking affected batches should contact their healthcare provider or pharmacist to determine if they have received one of the recalled products. Patients should not discontinue Colchicine without consulting their healthcare provider, as this medication is prescribed for serious medical conditions.
The recalled product
- Product
- 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…
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: a) E203821
- Exp. 05/2024
- b) E203822
- E206186
- Exp. 10/2024
- c) E203820
- Exp. 05/2024.
Distribution
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