Agency classClass IIOur severity:High FDA (Drugs)·D-0241-2023·Announced 2023-02-01

Vancomycin Ophthalmic Solutions Recalled for Sterility Assurance Concerns

Pharmacy Innovations is recalling vancomycin fortified ophthalmic solutions nationwide due to lack of sterility assurance. FDA inspection revealed insanitary conditions at the manufacturing facility.

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: Scores as High: involves a risk-of-harm product category (ophthalmic medications) where no injuries have been reported, matching the High severity criterion. FDA Class II classification with documented insanitary facility conditions reinforces this assessment.

Plain-English summary

Pharmacy Innovations is recalling multiple strengths of vancomycin fortified ophthalmic solutions distributed nationwide. The recalled products include vancomycin fortified 10 mg/mL (1 mL droptainer), vancomycin fortified 14 mg/mL (3 mL droptainer), vancomycin fortified-STS 50 mg/mL, and vancomycin-STS 25 mg/mL (2 mL droptainer) formulations.

The recall was initiated due to lack of assurance of sterility. FDA inspection of the manufacturing facility in Erie, Pennsylvania revealed insanitary conditions that could affect the sterility of the products.

The affected products were distributed nationwide. Lot codes associated with the recall include t20221122@15, t20221110@28, t20221027@33, and t20221020@5. These are prescription-only products that may have been dispensed through pharmacies.

Consumers and healthcare providers who have obtained these products should stop using them and consult with their healthcare provider regarding alternative treatment options.

The recalled product

Product: VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Manufacturer: Pharmacy Innovations
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
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 (1)

t20221122@15 t20221110@28 t20221027@33 t20221020@5

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations 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 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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