Recalls / Class III
Class IIID-216-2013
Product
PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716
- Affected lot / code info
- 2 AE1549 Exp. 02/13
Why it was recalled
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Recalling firm
- Firm
- L. Perrigo Co.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 60,048 Blister packs
- Distribution pattern
- Walmart Distribution Center in Bentonville, AR
Timeline
- Recall initiated
- 2013-02-18
- FDA classified
- 2013-03-22
- Posted by FDA
- 2013-04-03
- Terminated
- 2013-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-216-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.