Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Reason Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of…
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of…
Reason Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.