Dexamethasone Sodium Phosphate Otic Injection Syringes Recalled for Lack of Sterility Assurance
Edge Pharma LLC is recalling Dexamethasone sodium phosphate sterile otic solution for injection syringes (NDC 05446-0848-01) due to lack of assurance of sterility. Approximately 323 syringes were distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class II. Dexamethasone sodium phosphate is a sterile injectable product intended for otic injection; lack of sterility assurance in such products poses a significant risk of serious infection and potential hospitalization, meeting the severity criteria for a Class II recall.
Plain-English summary
Edge Pharma LLC is recalling Dexamethasone sodium phosphate, sterile otic solution for injection, preservative-free, 19.2 mg/0.8 mL (24 mg/mL) in 0.8 mL single-use syringes. The product is manufactured by Edge Pharma LLC at 856 Hercules Drive, Colchester, Vermont 05446, with NDC 05446-0848-01. The recall affects approximately 323 syringes distributed nationwide.
The recall was initiated due to lack of assurance of sterility. This is a Class II recall issued by the U.S. Food and Drug Administration.
Consumers and healthcare providers who have received this product should stop using it and contact Edge Pharma LLC or their healthcare provider for further guidance. The affected lot code is 09-2021-28@1 with an expiration date of 01/10/2022.
The recalled product
- Product
- Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable / Ophthalmic
- Hazard
- lack-of-sterility
- infection-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)
- 09-2021-28@1 01/10/2022
Distribution
Distributed nationwide across the United States.
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