Children's Cetirizine Hydrochloride Chewable Tablets recall
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.
Why was Children's Cetirizine Hydrochloride Chewable Tablets recalled?
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JKR5135A, Exp 11/17
- 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.
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 13,200 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 31, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)