RecallRadar

FDA Drug recall D-0226-2020

S-HCG 1200U/ML MDV INJ SOLN

On 2019-11-13 the FDA classified a Class II recall of S-HCG 1200U/ML MDV INJ SOLN by First Royal Care, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0226-2020
ClassificationClass II
Statusterminated
Initiated2019-08-12
Published2019-11-13
Last updated2026-09-13 11:52 UTC
CompanyFirst Royal Care
DistributionUS

Product

S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Lot #:a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/…Lot #:a) S07292019DH@01, Exp 9/29/19;S07232019DH@06, Exp 9/23/19;S06302019DH@05, Exp 8/30/19 b) S06112019DH@01, Exp 8/11/19; S06112019DH@11, Exp 8/11/19;S06142019DH@02, Exp 8/14/19; S06162019DH@01, 8/16/19,S06182019DH@34, Exp 8/18/19; S06242019DH@16, Exp 8/24/19; S06302019DH@05, Exp 8/30/19, S07102019DT@16, Exp 9/10/19; S07162019DH@02, Exp; 9/16/19, S07262019DH@03, Exp 9/26/19; S08022019DH@02, Exp 10/2/19; S07232019DH@06, Exp 9/23/19, c) S07102019DT@07, Exp 9/10/19;

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-0226-2020%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.