Agency classClass IIOur severity:High FDA (Drugs)·D-0060-2024·Announced 2023-10-25

TPC Drops Ophthalmic Solution Recalled for Lack of Sterility Assurance

Pine Pharmaceuticals is recalling TPC Drops ophthalmic solution due to lack of assurance of sterility. The recall affects 1693 droppers 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 a Class II recall of a prescription ophthalmic solution with lack of assurance of sterility, creating a risk of contamination and potential eye infections. No illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, a risk-of-harm product with no reported injury scores at most 3 (High).

Plain-English summary

Pine Pharmaceuticals, LLC is recalling TPC Drops ophthalmic solution (containing tropicamide 1%, phenylephrine 2.5%, and cyclopentolate HCl 1%) due to lack of assurance of sterility. The recall involves two lots: Lot #68184 (expiration 10/9/2023) and Lot #68623 (expiration 11/2/2023), totaling 1693 droppers.

The product is a compounded prescription ophthalmic solution distributed nationwide. Without assured sterility, the solution may become contaminated, potentially leading to eye infections or other serious complications when administered.

Consumers who have received this medication should contact their healthcare provider or pharmacist for guidance. Patients should not use this product without consulting their healthcare provider. Healthcare providers and pharmacies should remove affected lots from inventory and advise patients accordingly.

The recalled product

Product: TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Manufacturer: Pine Pharmaceuticals, LLC
Category: Drug — Ophthalmic / Eye Drops
Hazard: lack-of-sterility
contamination-risk
Affected units: 1,693

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 #: 68184
Exp. Date 10/9/2023
68623
Exp. Date 11/2/2023

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.

See all 16 products in this recall →

Same manufacturer · Pine Pharmaceuticals, LLC

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