RecallRadar

FDA Drug recall D-0226-2023

PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE

On 2023-02-01 the FDA classified a Class II recall of PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE by Pharmacy Innovations, citing lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0226-2023
ClassificationClass II
Statusterminated
Initiated2022-12-22
Published2023-02-01
Last updated2026-09-13 11:52 UTC
CompanyPharmacy Innovations
DistributionUS

Product

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.

Reason

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

Identifiers

code_infot20221011@7 t20221020@34 t20221018@58 t20221013@15 t20221104@39

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.