D-1296-2014 Class III Terminated
FDA drug recall D-1296-2014 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: 128,363 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
- 128,363 bottles
Product Description
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Distribution Pattern
Nationwide
Code Information
JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15