Drug 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
D-1297-2014
Product summary
- Event
- Event 67971
- Status
- Terminated
- Classification
- Class III
- Quantity
- 47,813 bottles
- Official record key
drug-enforcement:D-1297-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Code information: JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification