RecallRadar

FDA Drug recall D-0021-2025

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-0…

On 2024-10-30 the FDA classified a Class II recall of Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-0… by Fresenius Kabi Compounding, citing cGMP violations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0021-2025
ClassificationClass II
Statusterminated
Initiated2024-09-25
Published2024-10-30
Last updated2026-09-13 11:52 UTC
CompanyFresenius Kabi Compounding
DistributionUS

Product

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

Reason

cGMP violations

Identifiers

code_infoLot # C274-000038801, exp. date 9-Oct-24 C274-000039045, exp. date 24-Oct-24 C274-000039240, exp. date 31-Oct-24

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-0021-2025%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.