RecallRadar

FDA Drug recall D-0102-2023

Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way…

On 2023-01-18 the FDA classified a Class II recall of Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way… by Northern Va Compounders Pllc, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0102-2023
ClassificationClass II
Statusterminated
Initiated2022-12-30
Published2023-01-18
Last updated2026-09-13 11:52 UTC
CompanyNorthern Va Compounders Pllc
DistributionUS

Product

Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot#: 12062022@7, Exp 1/20/2023; 12072022@32, Exp 1/22/2023

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-0102-2023%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.