Drug product
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
D-1166-2014
Product summary
- Event
- Event 67617
- Status
- Terminated
- Classification
- Class III
- Quantity
- 70,704 bottles
- Official record key
drug-enforcement:D-1166-2014
Official wording
Reason: Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Code information: G85041
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent