Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0449-2022·Announced 2022-02-02

Trypan Blue Ophthalmic Solution Recalled for CGMP Deviations

Edge Pharma, LLC is recalling Trypan Blue 0.03% ophthalmic solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on December 6, 2021.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for CGMP deviations with no reported illnesses or injuries mentioned in the source text. The hazard is a manufacturing process deviation rather than a direct safety threat with documented harm, placing it in the moderate category.

Plain-English summary

Edge Pharma, LLC, located in Colchester, Vermont, is recalling Trypan Blue 0.03%, 0.5 mL per syringe, a sterile ophthalmic solution for intraocular injection. The product is preservative-free and supplied in single-use syringes with NDC 05446-1348-01.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The product was distributed nationwide. Affected lot codes include 09-2021-10, 09-2021-17, 09-2021-24, 09-2021-30, and 10-2021-13, distributed between December 9, 2021 and January 11, 2022.

This is a voluntary recall initiated by the firm. The FDA classified this as a Class II recall. Healthcare providers and patients who have this product should contact their supplier or the manufacturer for further guidance. The recall status was terminated on June 7, 2023.

The recalled product

Product: Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Ophthalmic Solution
Hazard: cgmp-deviation
manufacturing-process-deviation

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)

09-2021-10@3 12-09-2021
09-2021-17@6 12-16-2021
09-2021-24@8 12-23-2021
09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, 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 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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