Sandoz, Inc recalls Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count con
Recalled June 10, 2015 · FDA recall D-1115-2015 · Sandoz
Hazard
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point. · FDA Class III
Units
1,023,430 units
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
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
Manufacturer(s)
Sandoz, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →