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Recall Observatory FDA recall evidence

Drug product

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

D-0334-2026

February 05, 2026

Class II

Product summary

Firm
Fresenius Kabi Compounding, LLC
Event
Event 98391
Status
Ongoing
Classification
Class II
Quantity
1410 bags
Official record key
drug-enforcement:D-0334-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility