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Recall Observatory FDA recall evidence

Drug product

Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

D-0058-2024

October 02, 2023

Class II

Product summary

Firm
Pine Pharmaceuticals, LLC
Event
Event 93154
Status
Terminated
Classification
Class II
Quantity
2176 syringes
Official record key
drug-enforcement:D-0058-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 67623, Exp. Date 10/15/2023; 67919, Exp. Date 10/29/2023; 68917, Exp. Date 12/16/2023; 69079, Exp. Date 12/23/2023; 69120, Exp. Date 12/24/2023

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility