Neostigmine Methylsulfate Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable product with no reported illnesses or injuries. The hazard of sterility assurance failure in a high-risk product (compounded sterile injection) qualifies as a risk-of-harm scenario where injury has not yet been reported, meeting the High (3) severity threshold.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, supplied as 5 mL pre-filled syringes. The recall affects 64,450 syringes distributed nationwide.
The recall was issued because the manufacturer cannot assure that affected lots meet sterility standards required for injectable pharmaceutical products. Neostigmine Methylsulfate is used in healthcare settings for specific medical purposes, and any loss of sterility assurance presents a potential safety risk.
The following lots are affected: NE2001A (expiration 6/30/2022) and NE2009B (expiration 8/27/2022). Healthcare facilities and practitioners who received affected batches should stop use immediately and contact Nephron Sterile Compounding Center LLC or the FDA for guidance on disposal and replacement options.
The recalled product
- Product
- Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-902-05
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Hazard
- sterility-assurance
- 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 (4)
- Lots: NE2001A
- Exp. 6/30/2022
- NE2009B
- Exp. 8/27/2022
Distribution
Distributed nationwide across the United States.
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