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.
What this means for you
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27