RecallRadar

FDA Drug recall D-0662-2020

Alprostadil 40 mcg/mL (2 mL vial) Inj

On 2020-01-22 the FDA classified a Class II recall of Alprostadil 40 mcg/mL (2 mL vial) Inj by Assurance Infusion, citing lack of sterility assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0662-2020
ClassificationClass II
Statusterminated
Initiated2019-12-20
Published2020-01-22
Last updated2026-09-13 11:52 UTC
CompanyAssurance Infusion
DistributionUS

Product

Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

Reason

Lack of sterility assurance.

Identifiers

code_infoLots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020

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-0662-2020%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.