RecallRadar

FDA Drug recall D-0980-2020

Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutica…

On 2020-03-11 the FDA classified a Class II recall of Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutica… by Fusion Iv Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0980-2020
ClassificationClass II
Statusterminated
Initiated2020-01-15
Published2020-03-11
Last updated2026-09-13 11:52 UTC
CompanyFusion Iv Pharmaceuticals
DistributionUS

Product

Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #: 09132019+52914, Exp 2/28/2020; 09162019+52920, Exp 3/2/2020; 09192019+52939; Exp 2/28/2020; 10292019+53162, Exp 4/14/2020; 12112019+53369, Exp 5/27/2020

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-0980-2020%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.