Why it was recalled
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
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
Lot numbers, UPCs & expiration codes
NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-008-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 20, 2012
- FDA report date
- Oct 24, 2012
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-008-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 63224
- Address
- 2555 W Midway Blvd
- Code information
- NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
- Postal code
- 80020-1632
- Report date
- Oct 24, 2012
- Product type
- Drugs
- Recall number
- D-008-2013
- Classification
- Class III
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Termination date
- Jan 14, 2013
- Reason for recall
- Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 20, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 18, 2012