Class III
Terminated
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
- Recall Initiated
- April 9, 2014
- Posted
- May 7, 2014
- Recall Number
- D-1296-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 128,363 bottles
- Firm Location
- Detroit, MI, United States
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Distribution
Nationwide
Lot / Code Info
JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A Exp. 04/15
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