FDA Recalls Compounded Ophthalmic Solution Due to Sterility Concerns
Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.
What this means for you
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: FDA Class II recall of a risk-of-harm product (sterile ophthalmic solution for eye use) with no reported illnesses or injuries to date. The hazard is theoretical but serious.
Plain-English summary
Pine Pharmaceuticals, LLC is recalling Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution in 15 mL multi-use droppers. A total of 2,181 droppers have been identified as affected.
The recall was issued because the product lacks assurance of sterility as required by FDA standards. Ophthalmic solutions must be sterile to be safe for direct use in the eye.
The recalled product was distributed nationwide within the United States. Affected lot numbers are: 67008 (Exp. 10/04/2023), 67685 (Exp. 10/21/2023), 67853 (Exp. 10/25/2023), and 69967 (Exp. 01/13/2024).
Customers should stop using the product if they have any of the affected lots and consult their healthcare provider with any concerns. The product requires a prescription and was compounded by Pine Pharmaceuticals at their facility in Tonawanda, NY.
The recalled product
- Product
- Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Manufacturer
- Pine Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic
- Hazard
- sterility-failure
- contamination-risk
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 (8)
- Lot #: 67008
- Exp. Date 10/04/2023
- 67685
- Exp. Date 10/21/2023
- 67853
- Exp. Date 10/25/2023
- 69967
- Exp. Date 01/13/2024
Distribution
Distributed nationwide across the United States.
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