Class II · Moderate risk Ongoing
Phenylephrine Hydrochloride Injectable Solution
Reason cGMP deviations.
PE Daytime Cold/Flu LiqGel
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
What was recalled
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
- Recalling firm
- L. Perrigo Co.
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-216-2013
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.
Other Phenylephrine recalls
See all
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Reason Incorrect Product Formulation
Class II · Moderate risk Ongoing
Phenylephrine HCI
Reason CGMP Deviations
Class III · Low risk Completed
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk Ongoing
PHENYLephrine HCl in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
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