US Compounding Recalls Neostigmine Methylsulfate Syringes Due to Missing Labels
US Compounding Inc is recalling 1,640 syringes of Neostigmine Methylsulfate Injection because they are missing labels. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging/labeling defect (missing label) without reported injuries.
Plain-English summary
US Compounding Inc is recalling 1,640 syringes of Neostigmine Methylsulfate PF Injection, 5 mg/5 mL, 5 mL Single Use Syringes. The recall is due to a labeling defect where the product is missing its label. The affected lot is 20202109@3 with a beyond-use date of March 20, 2021.
The product is intended for hospital and office use only. It was distributed nationwide. The NDC for the product is 62295-3324-05.
Healthcare facilities should stop using the affected product and contact US Compounding Inc for further instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US Compounding 1270 Don's Lane Conway, AR 72032 (800) 718-3588 NDC 62295-3324-05
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,640
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: 20202109@3 BUD: 3/20/2021
Distribution
Distributed nationwide across the United States.
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