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Recall Observatory FDA recall evidence

Drug product

Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA 18103, PN: 69389-06229

D-0986-2022

May 24, 2022

Class II

Product summary

Firm
US Specialty Formulations LLC
Event
Event 90257
Status
Terminated
Classification
Class II
Quantity
781 vials
Official record key
drug-enforcement:D-0986-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 02RP1503A, exp. date 30-Sep-22; 02RP1506A, exp. date 31-Dec-22; 02RP1516A, exp. date 30-Jun-23

Distribution pattern: Product was distributed to medical facilities and a physician's office Nationwide in the USA.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility