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Recall Observatory FDA recall evidence

Drug 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.

D-0911-2018

June 29, 2018

Class I

Product summary

Firm
Fagron Compounding Services LLC dba Fagron Sterile Services
Event
Event 80383
Status
Terminated
Classification
Class I
Quantity
390 prefilled syringes
Official record key
drug-enforcement:D-0911-2018

Official wording

Reason: Labeling: Label Error on Declared Strength: 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.

Code information: Lot #: C274-000004678, BUD: 09/20/18

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error