FDAFDA · Food and drugs·Recall number D-008-2013
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Published October 24, 2012 · Recall initiated: September 20, 2012
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
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CETIRIZINE HYDROCHLORIDE
- Manufacturer
- Sandoz Incorporated
- Distributor
- Nationwide
- Lot
- NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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