FDA Recalls Tropi-Phen Ophthalmic Solution Due to Sterility Assurance Failure
Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—lack of sterility assurance in an ophthalmic product—represents a risk-of-harm where injury has not yet been reported, fitting the Score 3 criterion in the severity rubric.
Plain-English summary
Pine Pharmaceuticals, LLC has recalled Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution due to lack of assurance of sterility. A total of 662 units in 5mL multi-use dropper bottles have been recalled.
The recall affects two lot numbers: Lot #67659 (expiration date 10/16/2023) and Lot #70316 (expiration date 1/30/2024). These lots were distributed nationwide throughout the United States.
Patients using this product should contact their healthcare provider or pharmacist. Do not use the recalled product and return it to the pharmacy where it was dispensed.
The recalled product
- Product
- 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.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 662
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 67659
- Exp. Date 10/16/2023
- 70316
- Exp. Date 1/30/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Pine Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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