FDAClass IIFebruary 1, 2023

Pe1/papav/phen 20mcg/30mg/2mg/ml recall: Sterility Concern

PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN…

Why was Pe1/papav/phen 20mcg/30mg/2mg/ml recalled?

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

t20221018@32 t20221108@89 t20221013@18 t20221031@11 t20221010@18 t20221101@1 20221108@18 t20221101@3 t20221027@32 t20221123@10 t20221013@15 t20221003@37 t20221021@32 t20221108@3 t20221011@36 t20221108@24 t20221021@43 t20221026@5 t20221123@15 t20221111@58 t20221013@15 t20221116@36 t20221128@2 t20221011@36 t20221108@24 t20221116@57 t20221007@33 t20221111@39 t20221011@36 t20221108@24 t20221128@45 t20221116@36 t20221011@36 t20221116@36 t20221104@34 t20221018@61 t20221116@36 t20221111@19 t20221011@36 t20221108@24 t20221108@64 t20221116@36 t20221117@11 t20221114@21 t20221108@33 t20221010@22 t20221004@44 t20221121@49

Product
PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN…
Recalling firm
Pharmacy Innovations
Quantity
N/A
Distribution
Nationwide in the USA
Recall date
February 1, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls