← FDA ENFORCEMENT
D-0056-2024Class II

Pine Pharmaceuticals, LLC

Recalling firm
Pine Pharmaceuticals, LLC
Product type
Drug
Status
Terminated
Report date
2023-10-25
Distribution
Nationwide within the United States
Firm state
NY
Product quantity
2484 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Code / lot info

Lot #: 67480, Exp. Date 10/9/2023; 68640,Exp. Date 12/3/2023; 68769, Exp. Date 12/9/2023; 68760, Exp. Date 12/10/2023; 68925, Exp. Date 12/16/2023;70119, Exp. Date 1/20/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.