Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
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 Tablet/Capsule Specifications
Reason Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
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