Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures
Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product failed impurities and degradation specifications.
What this means for you
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 FDA Class III, which indicates a low probability of adverse health consequences, aligning with the Moderate severity rating for minor labeling or specification errors without reported harm.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Carvediol Tablets, USP, 25 mg, in 100-count, 500-count, and 1000-count bottles. The recall involves 3,889 HDPE bottles distributed nationwide. The affected lots are AVF0258/A, AVF0258/B, AVF0258/C, AVF0259/A, and AVF0259/C, all with an expiration date of 02/17.
The recall was initiated because the product failed impurities and degradation specifications. The tablets were manufactured by ALKALOIDA Chemical Company Zrt in Hungary and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers who have these specific bottles should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical I
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,889
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 (6)
- Lot # AVF0258/A
- AVF0258/B
- AVF0258/C
- AVF0259/A
- AVF0259/C
- Exp. 02/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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