Multiple injectable medications recalled for sterility assurance concerns
Pharmacy Innovations recalls multiple injectable medications nationwide due to insanitary facility conditions compromising sterility assurance. FDA inspection revealed conditions creating risk to medication safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of injectable medications due to insanitary facility conditions compromising sterility assurance. Although no illnesses or injuries are reported in the source, potential sterility failure in injectable drugs represents a significant risk of harm to patients per the severity rubric.
Plain-English summary
Pharmacy Innovations is recalling multiple injectable medication formulations distributed nationwide. The recalled products include various combinations of phenylephrine, papaverine, phentolamine, and in some cases atropine, supplied in 1-milliliter vials.
The recall was initiated following an FDA inspection of the Pharmacy Innovations manufacturing facility located in Erie, Pennsylvania. The inspection revealed insanitary conditions that create a lack of assurance regarding the sterility of these medications.
These medications were distributed nationwide. Consumers, pharmacies, and healthcare providers in possession of affected medications should not use them. The recalled medications are identified by lot codes from October through November 2022. Patients should contact their healthcare provider or pharmacy for information about alternative treatments.
The recalled product
- Product
- PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABL
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Injectable medications
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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