Sandoz, Inc recalls Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count co…

Recall date

April 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1115-2015

FDA classification

Class III

Brand / firm

Sandoz, Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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