RecallRadar

FDA Drug recall D-1208-2022

Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

On 2022-07-20 the FDA classified a Class II recall of Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1208-2022
ClassificationClass II
Statusongoing
Initiated2022-03-07
Published2022-07-20
Last updated2026-09-13 11:52 UTC
CompanyTmc Acquisition
DistributionUS

Product

Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding

Reason

Lack of Assurance of Sterility

Identifiers

code_infoBatch#: 12222104A2, Exp 3/22/2022; 01032224A2, Exp 4/3/2022; 01282217A2, Exp 4/28/2022; 02192211A1; Exp 5/20/2022.

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-1208-2022%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.