Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
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 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
Compare with the code on your package — it is the most precise check available.
Drug: Cetirizine Category: Allergy & Cold Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
CGMP deviations.
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