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
Product summary
- 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
Labeling: Label Error