D-1166-2014 Class III Terminated
FDA drug recall D-1166-2014 was initiated by Pfizer Us Pharmaceutical Group on February 26, 2014 and is designated Class III. Reason for recall: Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. The recall status is terminated (terminated July 10, 2015). Affected quantity: 70,704 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 26, 2014
- Initiation Date
- February 26, 2014
- Termination Date
- July 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70,704 bottles
Product Description
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Reason for Recall
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Distribution Pattern
Nationwide
Code Information
G85041