Reported May 7, 2014 · Terminated
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC…
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?
- Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
- Lot codes and dates
JKM2067A Exp. 07/14JKM2068A Exp.10/14JKM2069A Exp. 01/15JKM6399A Exp. 04/15
- Amount recalled
- 128,363 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Caraco Pharmaceutical Laboratories, Ltd. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.