Status
Terminated
Drug Enforcement D-008-2013
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Classification
Class III
Report Date
October 24, 2012
Termination Date
January 14, 2013
Product Information
- 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
- Product quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Reason for recall
- Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Sandoz Incorporated
- Address
-
2555 W Midway Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-008-2013
- Event ID
- 63224
- Recall initiation date
- September 20, 2012
- Center classification date
- October 18, 2012
- Code info
- NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
- More code info
- —