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Recall Observatory FDA recall evidence

Drug product

Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

D-0065-2024

October 02, 2023

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 93154
Status
Terminated
Classification
Class II
Quantity
136 syringes
Official record key
drug-enforcement:D-0065-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 68680, Exp. Date 12/4/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility