Neostigmine Methylsulfate Injectable Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Neostigmine methylsulfate 5 mg/5mL single-use syringes for IV or IM injection due to lack of assurance of sterility. Approximately 160 syringes nationwide may be affected.
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 is an FDA Class II recall of an injectable pharmaceutical product. The lack of sterility assurance in a sterile parenteral product poses a risk of serious infection that could require hospitalization. Injectable products with sterility defects are inherently serious due to the direct introduction into the body.
Plain-English summary
Edge Pharma, LLC is recalling Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), supplied in 5 mL single-use syringes for intravenous or intramuscular injection. The product is manufactured by Edge Pharma, LLC, located at 856 Hercules Drive, Colchester, Vermont.
The recall is due to a lack of assurance of sterility. Approximately 160 syringes with lot code 10-2021-07@1 and expiration date 01/19/2022 have been distributed nationwide.
Patients or healthcare providers who have received this product should consult with their healthcare provider regarding potential risks and appropriate medical management. The product should not be used.
The recalled product
- Product
- Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable / Parenteral
- Hazard
- sterility-assurance
- infection-risk
- contamination
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)
- 10-2021-07@1 01/19/2022
Distribution
Distributed nationwide across the United States.
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