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Policy version 2026-07-21, effective July 21, 2026.
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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
by Sandoz Incorporated
Reason
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
This page lists recalls that name Sandoz Incorporated as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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