Drug product
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
D-1115-2015
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 71055
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,023,430 units
- Official record key
drug-enforcement:D-1115-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Code information: Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification