RecallRadar

FDA Drug recall D-1256-2019

HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded

On 2019-05-08 the FDA classified a Class II recall of HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded by Customceutical Compounding, citing lack of assurance of sterility for injectables and solutions intended to be sterile.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1256-2019
ClassificationClass II
Statusterminated
Initiated2019-04-08
Published2019-05-08
Last updated2026-09-13 11:52 UTC
CompanyCustomceutical Compounding
DistributionUS

Product

HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Reason

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Identifiers

code_infoLot #: 03132019@23, Exp 5/12/19

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-1256-2019%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.