Neostigmine methylsulfate injection recalled nationwide due to sterility concerns
SCA Pharmaceuticals is recalling 1,122 syringes of neostigmine methylsulfate injection nationwide due to inability to assure product sterility. The affected lot is 1223048138 (expiration 1/31/24).
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 for lack of sterility assurance in an injectable medication. No illnesses or injuries have been reported, but sterility failure poses a potential risk of infection to patients.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling neostigmine methylsulfate 5 mg/5 mL injection nationwide. The affected product was distributed across the United States, with approximately 1,122 syringes involved in the recall.
The recall is due to lack of assurance of sterility. The affected lot is 1223048138 with an expiration date of January 31, 2024, and carries NDC 70004-0750-09.
Patients and healthcare providers holding this product should not use it. Affected individuals should consult their healthcare provider regarding alternative treatment options and proper disposal of the recalled product.
The recalled product
- Product
- neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable medication
- Hazard
- lack-of-sterility
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)
- Lot #: 1223048138 exp 1/31/24
Distribution
Distributed nationwide across the United States.
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