Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
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.
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Compare with the code on your package — it is the most precise check available.
Drug: Cetirizine Category: Allergy & Cold Medication
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.
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
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