Class III
Terminated
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
- Company
- Sandoz Inc
- Recall Initiated
- April 15, 2015
- Posted
- June 10, 2015
- Recall Number
- D-1115-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,023,430 units
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Distribution
Nationwide
Lot / Code Info
Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
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