D-1297-2014 Class III Terminated
FDA drug recall D-1297-2014 was initiated by Caraco Pharmaceutical Laboratories, Ltd. on April 9, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide The recall status is terminated (terminated October 7, 2014). Affected quantity: 47,813 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- April 9, 2014
- Termination Date
- October 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,813 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Distribution Pattern
Nationwide
Code Information
JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15