Drug Enforcement D-0226-2023

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

Status

Terminated

Classification

Class II

Report Date

February 1, 2023

Termination Date

July 31, 2024

Product Information

Product description
PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Product quantity
N/A
Reason for recall
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Pharmacy Innovations
Address
2936 W 17th St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0226-2023
Event ID
91332
Recall initiation date
December 22, 2022
Center classification date
January 26, 2023
Code info
t20221011@7 t20221020@34 t20221018@58 t20221013@15 t20221104@39
More code info
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