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Recall Observatory FDA recall evidence

Drug product

Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

D-0059-2024

October 02, 2023

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 93154
Status
Terminated
Classification
Class II
Quantity
9673 vials
Official record key
drug-enforcement:D-0059-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 67849, Exp. Date 10/25/2023; 67887, Exp. Date 10/28/2023; 68260, Exp. Date 11/14/2023; 68534, Exp. Date 11/27/2023; 68816, Exp. Date 12/12/2023; 69046, Exp. Date 12/20/2023; 69971, Exp. Date 1/13/2024

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility