Product: Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Reason for recall: Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Recall initiated: 20150415
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated