Recalls / Class III
Class IIID-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
- Brand name
- Cetirizine Hydrochloride
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDC
- 0781-5283
- FDA application
- ANDA078692
- Affected lot / code info
- NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Why it was recalled
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Recalling firm
- Firm
- Sandoz Incorporated
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-09-20
- FDA classified
- 2012-10-18
- Posted by FDA
- 2012-10-24
- Terminated
- 2013-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-008-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.