Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error
Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution because they 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 minimum severity score of 4 according to the rubric.
Plain-English summary
Fagron Compounding Services LLC dba Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution. The product is identified by NDC 71266-2003-02, Lot # C274-000004690, and a beyond-use date of 09/21/18. The syringes were distributed nationwide in the USA.
The recall was initiated due to a labeling error regarding the declared strength. Syringes containing 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 could lead to incorrect dosing if the product is used.
Healthcare providers and patients should check their inventory for the specific lot number and beyond-use date listed above. If the product is found, it should be removed from use and returned to the distributor or the recalling firm. Consumers should consult their healthcare provider for guidance on any medication they have already received.
The recalled product
- Product
- Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 840
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 #: C274-000004690
- BUD: 09/21/18.
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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