Cetirizine Hydrochloride Chewable Tablets recall: Impurity Out of Spec
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Why was 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?
JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
- Product
- Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Quantity
- 128,363 bottles
- Distribution
- Nationwide
- Recall date
- May 7, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)