FDA recall D-008-2013

Product

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)

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-09-20

Report date

2012-10-24

Termination date

2013-01-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-008-2013