Children's Cetirizine Hydrochloride Chewable Tablets recall: Impurity Out of Spec
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug…
Why was Children's Cetirizine Hydrochloride Chewable Tablets recalled?
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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?
JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
- Product
- Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug…
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Quantity
- 47,813 bottles
- Distribution
- Nationwide
- Recall date
- May 7, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)