← FDA ENFORCEMENT
D-0062-2024Class 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
1598 droppers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Code / lot info

Lot #: 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023

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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.