Sandoz Recalls Cetirizine HCl Chewable Tablets Due to Impurity Failure

Plain-English summary

Sandoz, Inc. is recalling approximately 1,023,430 units of Cetirizine HCl Chewable Tablets, 10 mg. The affected products are distributed in 12-tablet and 24-tablet blister configurations and were manufactured in India for Sandoz, Inc. The recall covers specific lot numbers with expiration dates of May 2015 and July 2015.

The recall was initiated because an out-of-specification result was reported for an impurity at the 21-month stability time point. This indicates that the product failed to meet established impurity or degradation specifications during stability testing.

Consumers who have these specific lots of Cetirizine HCl Chewable Tablets should stop using them and contact their healthcare provider or pharmacist for guidance. The affected lots are identified by the following codes: DP3841, DP5237, DP5238, DP5238A, DP5238B (Exp 05/2015) and DR7807, DR9954, DR9959, DV5838 (Exp 07/2015).

The recalled product

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 R

Manufacturer

Sandoz, Inc

Category

Drug — Antihistamine

Hazard

• impurity

Affected units

1,023,430

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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