Reported Oct 24, 2012 · Terminated
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd.,…
Sandoz Incorporated
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Incorporated · 2555 W Midway Blvd · Broomfield, CO · 80020-1632
Is this the product you have?
- 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
- Lot codes and dates
- NDC 0781-5283-64 lots
BT2862BT7986BT7994BW0652CC1961and CA3437NDC 0904-5878-33 lot BW0665
- NDC 0781-5283-64 lots
- Amount recalled
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Where it was sold
- Nationwide
Why it was recalled
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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