RecallRadar

FDA Drug recall D-1228-2022

Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding

On 2022-07-20 the FDA classified a Class II recall of Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1228-2022
ClassificationClass II
Statusongoing
Initiated2022-03-07
Published2022-07-20
Last updated2026-09-13 11:52 UTC
CompanyTmc Acquisition
DistributionUS

Product

Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Batch #: 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 1116…Batch #: 10122102A2, Exp 3/22/2022; 10252101A2, Exp 3/24/2022; 11092106A2, Exp 4/8/2022; 11232102A1, Exp 5/7/2022; 11162106A1, Exp 5/15/2022; 12032114A1, 02212224A1, Exp 5/22/2022; 12142111A1, 12202109A2, Exp 5/24/2022; 03032244A1, Exp 6/1/2022; 03082209A1, Exp 6/6/2022; 12292116A2, Exp 6/27/2022; 01182204A1, 01262232A1, 01262233A1, Exp 6/30/2022.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1228-2022%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.