Why it was recalled
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Product description
Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Lot numbers, UPCs & expiration codes
Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
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-1115-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 15, 2015
- FDA report date
- Jun 10, 2015
- Quantity
- 1,023,430 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-1115-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71055
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
- Postal code
- 08540-6243
- Report date
- Jun 10, 2015
- Product type
- Drugs
- Recall number
- D-1115-2015
- Classification
- Class III
- Recalling firm
- Sandoz, Inc
- Product quantity
- 1,023,430 units
- Termination date
- Oct 5, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 3, 2015