Glenmark Recalls Abiraterone Acetate Tablets Due to Labeling Error
Glenmark Pharmaceuticals is recalling 1,296 bottles of Abiraterone Acetate 500 mg tablets nationwide due to a labeling issue.
The agency’s classification
FDA (Drugs): Class II
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.
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: The recall is classified as Class II due to a labeling issue. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling 1,296 bottles of Abiraterone Acetate Tablets USP 500 mg. The product is distributed nationwide within the United States. The specific lot number is 13250135 with an expiration date of 11/2027.
The recall was initiated due to a labeling issue classified as 'Not Elsewhere Classified.' The source text does not specify the exact nature of the labeling error or report any illnesses, injuries, or deaths associated with the product.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ABIRATERONE ACETATE (ABIRATERONE ACETATE)
- Brand
- ABIRATERONE ACETATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 1,296
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 (2)
- Lot #: 13250135
- Exp. Date 11/2027
UPCs (1)
- 0368462882603
Distribution
Distributed nationwide across the United States.
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