Drug Recall: Dexamethasone Sodium Phosphate Topical Solution
Edge Pharma, LLC is recalling Dexamethasone sodium phosphate 0.4% topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed in 56 cartons.
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 involving manufacturing process deviations (CGMP violations). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is procedural rather than related to a specific contamination or defect. Class II recalls without reported harm typically score 2 under the rubric.
Plain-English summary
Edge Pharma, LLC is voluntarily recalling Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, a multiple-dose topical ophthalmic solution, due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
The recalled product, NDC 05446-0622-01, was manufactured in Vermont and distributed nationwide. Affected lot codes are 06-2021-23@6 (dated 12-20-2021), 09-2021-15@4 (dated 03-14-2022), and 10-2021-04@10 (dated 04-02-2022). A total of 56 cartons were distributed.
Patients or healthcare providers who have this product should discontinue use and contact their pharmacist or physician for guidance. The FDA classified this as a Class II recall on January 24, 2022, and the firm initiated the recall on December 6, 2021.
The recalled product
- Product
- Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Topical Ophthalmic
- Affected units
- 56
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 (2)
- 06-2021-23@6 12-20-2021
- 09-2021-15@4 03-14-2022 & 10-2021-04@10 04-02-2022
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.
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