Recalls / Class III
Class IIID-1166-2014
Product
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
- Brand name
- Advil Pm
- Generic name
- Diphenhydramine Citrate And Ibuprofen
- Active ingredients
- Diphenhydramine Citrate, Ibuprofen
- Route
- Oral
- NDC
- 0573-0164
- FDA application
- NDA021394
- Affected lot / code info
- G85041
Why it was recalled
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Recalling firm
- Firm
- Pfizer Us Pharmaceutical Group
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 70,704 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-02-26
- FDA classified
- 2014-03-18
- Posted by FDA
- 2014-03-26
- Terminated
- 2015-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1166-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.