Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Cetirizine Category: Allergy & Cold Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cetirizine Hydrochloride NDC 00781-5283 |
5 mg/1 | Tablet, Chewable Oral |
Sandoz Inc | OTC |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Tablet/Capsules Imprinted with Wrong ID
Tablet/Capsules Imprinted with Wrong ID
CGMP Deviations
CGMP Deviations: product held outside appropriate storage temperature conditions.
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Cross Contamination With Other Product: Imipramine
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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