Drug product
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
D-1296-2014
Product summary
- Event
- Event 67971
- Status
- Terminated
- Classification
- Class III
- Quantity
- 128,363 bottles
- Official record key
drug-enforcement:D-1296-2014
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Code information: JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification