Recalls / Class III
Class IIID-1115-2015
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
- Affected lot / code info
- Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
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.
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 1,023,430 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-15
- FDA classified
- 2015-06-03
- Posted by FDA
- 2015-06-10
- Terminated
- 2016-10-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1115-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.