RecallRadar

FDA Drug recall D-1195-2022

Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding

On 2022-07-20 the FDA classified a Class II recall of Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1195-2022
ClassificationClass II
Statusongoing
Initiated2022-03-07
Published2022-07-20
Last updated2026-09-13 11:52 UTC
CompanyTmc Acquisition
DistributionUS

Product

Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Batch #: a) 02282223A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 11032108A1, Exp 4/30/2022; 11222101A2, Exp 5/21/2022;…Batch #: a) 02282223A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 11032108A1, Exp 4/30/2022; 11222101A2, Exp 5/21/2022; b) 01042234B, Exp 7/3/2022; 01242211A2, Exp 7/23/2022; 02282222A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 10182101A1, Exp 4/16/2022; 11162112A1, Exp 5/15/2022; 12062105A2, Exp 6/4/2022; 12142143A2, Exp 6/12/2022; 12202102A2, Exp 6/18/2022.

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-1195-2022%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.