Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bo
Manufacturer / Brand: Bell Pharmaceuticals, Inc
Reason for Recall
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Date Issued
Category
Medications
Status
unknown
Issuing Agency
FDA CDER
What to do if you're affected
- →Check the lot number on your medication package against the specific lots listed in the recall notice — not every batch is always affected.
- →Do not stop a prescription medication without first consulting your doctor or pharmacist. Abrupt discontinuation of some drugs carries serious risks.
- →Contact your pharmacy — they can verify whether your dispensed lot is affected and arrange a replacement prescription.
- →For most insurance plans, a replacement fill triggered by a recall is covered even before the normal refill date.
- →Report any adverse effects to the FDA at 1-800-FDA-1088 or through MedWatch at fda.gov/safety/medwatch.
About the FDA CDER
This recall was issued by or conducted in cooperation with the FDA's Center for Drug Evaluation and Research (CDER), which oversees prescription and over-the-counter medications sold in the United States. Drug recalls may be initiated voluntarily by the manufacturer or at FDA's request after a quality problem is identified through manufacturer testing, FDA inspection, or adverse event reports. Recalls are classified by severity: Class I involves products that may cause serious injury or death; Class II and III involve lower levels of risk. Do not stop a prescription medication due to a recall without first consulting your doctor or pharmacist.
View all FDA CDER recalls →Opens the official government source. Always refer to official sources for the most current information.