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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

D-0064-2024

October 02, 2023

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 93154
Status
Terminated
Classification
Class II
Quantity
860 syringes
Official record key
drug-enforcement:D-0064-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 67808, Exp. Date 10/23/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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