FDA Drug recall D-1090-2019

PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy…

FDA Drug
Class II
terminated
Published 2019-04-17

On 2019-04-17 the FDA classified a Class II recall of PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy… by Health Solutions Pharmacy Center, citing lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1090-2019
Classification	Class II
Status	terminated
Initiated	2019-02-21
Published	2019-04-17
Last updated	2026-09-13 11:52 UTC
Company	Health Solutions Pharmacy Center
Distribution	OR

Product

PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330

Reason

Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.

Identifiers

code_info	Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18,… Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18, 01102018@9, 12102018@18, 12102018@18, 17102018@15, 12102018@18, 2102018@18, 22102018@31, 30102018@22, 29102018@9,29102018@9 29102018@9, 29102018@9, 12102018@18, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 11122018@7, 11122018@7, 28122018@11, 28122018@11, 28122018@11, 03012019@17, 03012019@17, 03012019@17, 08012019@21, 08012019@21,28082018@16 28082018@16, 28082018@16, 14092018@28, 14092018@28, 4092018@28, 14092018@28, 18092018@52, 18092018@52, 8092018@52, 18092018@52, 18092018@52, (b) 29102018@9, 03012019@17,14092018@28, (c) 11012019@64, 11012019@64, 11012019@64, 05022019@27, 5022019@27, 06022019@6, 06022019@6, distributed between 09-01-2018 to 02-20-2019.

code_info

Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18,…

Lot: (a) 18092018@52, 01102018@9, 05102018@36, 08102018@11, 102018@9, 01102018@9, 01102018@9, 03102018@27, 12102018@18, 01102018@9, 12102018@18, 12102018@18, 17102018@15, 12102018@18, 2102018@18, 22102018@31, 30102018@22, 29102018@9,29102018@9 29102018@9, 29102018@9, 12102018@18, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 21112018@38, 11122018@7, 11122018@7, 28122018@11, 28122018@11, 28122018@11, 03012019@17, 03012019@17, 03012019@17, 08012019@21, 08012019@21,28082018@16 28082018@16, 28082018@16, 14092018@28, 14092018@28, 4092018@28, 14092018@28, 18092018@52, 18092018@52, 8092018@52, 18092018@52, 18092018@52, (b) 29102018@9, 03012019@17,14092018@28, (c) 11012019@64, 11012019@64, 11012019@64, 05022019@27, 5022019@27, 06022019@6, 06022019@6, distributed between 09-01-2018 to 02-20-2019.

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-1090-2019%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.