Reported May 7, 2014 · Terminated
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat,…
Caraco Pharmaceutical Laboratories, Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caraco Pharmaceutical Laboratories, Ltd. · 1150 Elijah McCoy Dr · Detroit, MI · 48202-3344
Is this the product you have?
- Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
- Lot codes and dates
JKM2070A Exp. 07/14JKM2071A Exp.10/14JKM2072A Exp. 01/15JKM2072B Exp. 01/15JKM6400A Exp. 04/15
- Amount recalled
- 47,813 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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