Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities and degradation levels above or near specification limits.
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 FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or specification failures without reported harm.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count boxes. The recall affects 9,528 units distributed nationwide in the USA by CVS Pharmacy, Inc. The specific lot number is GKT0484B with an expiration date of 04/2020.
The recall was initiated because testing of the Fexofenadine HCl and Pseudoephedrine components failed impurities and degradation specifications. The results indicated elevated substance levels that were reported above or near the specification limit.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is distributed by CVS Pharmacy, Inc., located in Woonsocket, RI.
The recalled product
- Product
- Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 30-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 39131 0
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Hazard
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: GKT0484B
- EXP 04/2020
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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