Sun Pharmaceutical Recalls Allergy Relief D Tablets Due to Impurities
Sun Pharmaceutical is recalling Allergy Relief D tablets because testing showed impurities 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count boxes. The recall involves 17,136 units of Lot GKT0791 with an expiration date of 06/2020. The product was distributed nationwide in the USA by CVS Pharmacy, Inc.
The recall was initiated because testing of Fexofenadine HCl and Pseudoephedrine failed impurities/degradation specifications. Specifically, elevated substance results were reported above or near the specification limit. The agency has classified this as a Class II recall.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release Tablets, USP, 20-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895. Made in India. UPC 0 50428 43023 1
- 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 GKT0791
- EXP 06/2020
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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