Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error
Fagron Compounding Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution because some may be incorrectly labeled with the wrong strength.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it poses a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Fagron Compounding Services LLC dba Fagron Sterile Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only. The product is identified by NDC 71266-2003-01, Lot # C274-000004678, and a Beyond Use Date of 09/20/18.
The recall was initiated due to a labeling error where syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL. This discrepancy in the declared strength on the label could lead to medication administration errors.
The affected product was distributed nationwide in the USA. Healthcare providers and patients should verify the labeling on their Neostigmine Methylsulfate syringes against the specific lot and NDC numbers provided. If the product matches the recalled description, it should be returned to the pharmacy or manufacturer for disposal or replacement.
The recalled product
- Product
- Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
- Category
- Drug — Injection
- Hazard
- Affected units
- 390
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 (2)
- Lot #: C274-000004678
- BUD: 09/20/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Fagron Compounding Services LLC dba Fagron Sterile Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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