Children's Cetirizine HCl Chewable Tablets 5 mg recall: Impurity Out of Spec
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ…
Why was Children's Cetirizine HCl Chewable Tablets 5 mg recalled?
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
- Product
- Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ…
- Recalling firm
- Sandoz Incorporated
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Distribution
- Nationwide
- Recall date
- October 24, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)