Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Tablet/Capsule Specifications
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
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 Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Reason CGMP Deviations
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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