Class III · Lower riskRecall completed
Cetirizine HCl Chewable Tablet
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made bySandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540 foreign manufacturer
| Distributed by / for | Sandoz, Inc |
| NDC | 66394-041-06 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Sandoz, Inc |
| Distribution | Nationwide |
| Quantity | 1,023,430 units |
| Recall initiated | 2015-04-15 |
| Report date | 2015-06-10 |
| Recall completed | 2016-10-05 |
| Recall number | D-1115-2015 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.