Home / Recalls / Fresenius Kabi Compounding, LLC / D-0021-2025

D-0021-2025 Class II Terminated

Recalled by Fresenius Kabi Compounding, LLC — Canton, MA

FDA drug recall D-0021-2025 was initiated by Fresenius Kabi Compounding, LLC on September 25, 2024 and is designated Class II. Reason for recall: cGMP violations The recall status is terminated (terminated August 15, 2025). Affected quantity: 4436 bags.

Recall Details

Product Type: Drugs
Report Date: October 30, 2024
Initiation Date: September 25, 2024
Termination Date: August 15, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4436 bags

Product Description

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 for Recall

cGMP violations

Distribution Pattern

Product was distributed to 125 direct accounts nationwide.

Code Information

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

Other recalls by Fresenius Kabi Compounding, LLC

D-0333-2026 Class II — acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, (February 5, 2026)
D-0336-2026 Class II — vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injec (February 5, 2026)
D-0335-2026 Class II — thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, US (February 5, 2026)
D-0334-2026 Class II — ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride In (February 5, 2026)
D-0337-2026 Class II — vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection (February 5, 2026)
D-0016-2025 Class II — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single D (September 25, 2024)
D-0020-2025 Class II — NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, S (September 25, 2024)
D-0014-2025 Class II — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single D (September 25, 2024)
D-0023-2025 Class II — Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose (September 25, 2024)
D-0022-2025 Class II — EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, (September 25, 2024)