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
Reported: October 24, 2012 Initiated: September 20, 2012 #D-008-2013
Product Description
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
Reason for Recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Distribution
- Nationwide
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Incorporated. Units affected: 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons.
Why was this product recalled? ▼
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2012. Severity: Low. Recall number: D-008-2013.
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