Recalls / Class III
Class IIID-1297-2014
Product
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
- Brand name
- Cetirizine Hydrochloride
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDCs
- 47335-343, 47335-344
- FDA application
- ANDA090142
- Affected lot / code info
- JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 47,813 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-09
- FDA classified
- 2014-05-01
- Posted by FDA
- 2014-05-07
- Terminated
- 2014-10-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1297-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.