Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
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: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations
Reason Failed Tablet/Capsule Specifications
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Reason Failed Impurities/Degradation Specifications - at 18-month Stability testing
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