RecallRadar

FDA Drug recall D-0734-2020

HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

On 2020-01-22 the FDA classified a Class II recall of HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 by Assurance Infusion, citing lack of sterility assurance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0734-2020
ClassificationClass II
Statusterminated
Initiated2019-12-20
Published2020-01-22
Last updated2026-09-13 11:52 UTC
CompanyAssurance Infusion
DistributionUS

Product

HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

Reason

Lack of sterility assurance.

Identifiers

code_infoLots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020

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-0734-2020%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.