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Recall Observatory FDA recall evidence

Drug product

Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

D-0055-2024

October 02, 2023

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 93154
Status
Terminated
Classification
Class II
Quantity
2181 droppers
Official record key
drug-enforcement:D-0055-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 67008, Exp. Date 10/04/2023; 67685, Exp. Date 10/21/2023; 67853, Exp. Date 10/25/2023; 69967, Exp. Date 01/13/2024

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility