Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures
Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets because they failed impurity 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 the product is unlikely to cause adverse health consequences. The hazard involves failed impurity specifications without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 4,656 bottles of Carvediol Tablets, USP, 3.125 mg. The affected products are available in 100-count, 500-count, and 1000-count bottles and were distributed nationwide. The specific lot numbers involved are AVF0246/A, AVF0247/B, AVF0246/B, and AVF0246/C, all with an expiration date of 02/17.
The recall was initiated because the tablets failed to meet impurities and degradation specifications. The products were manufactured by ALKALOIDA Chemical Company Zrt in Hungary and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 4,656
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 (5)
- Lot #: AVF0246/A
- AVF0247/B
- AVF0246/B
- AVF0246/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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