FDAFDA · Food and drugs·Recall number D-1115-2015
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
Published June 10, 2015 · Recall initiated: April 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sandoz, Inc
- Distributor
- Nationwide
- Lot
- Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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