← FDA ENFORCEMENT
D-0063-2024Class 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
662 dropper
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Code / lot info

Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024

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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.