D-0022-2025 Class II Terminated

Recall Details

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

cGMP violations

Product was distributed to 125 direct accounts nationwide.

Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24

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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-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-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-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-0021-2025 Class II — Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag (September 25, 2024)
D-0019-2025 Class II — NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 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)