Sun Pharmaceutical Recalls Children's Cetirizine Tablets for Hardness Issues
Sun Pharmaceutical Industries is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets due to out-of-specification tablet hardness.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a physical specification failure (hardness) rather than a chemical or biological hazard.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 13,200 bottles of Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottles. The product is identified by Lot # JKR5135A and expiration date 11/17. The recall was initiated because the tablets failed to meet specifications for tablet hardness, resulting in out-of-specification results for increased hardness.
The affected product was distributed nationwide in the USA and Puerto Rico. The tablets are manufactured by Sun Pharmaceutical Ind. Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact Sun Pharmaceutical Industries for further instructions.
The recalled product
- Product
- Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 13,200
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 #: JKR5135A
- Exp 11/17
Distribution
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