D-0911-2018 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2018
- Initiation Date
- June 29, 2018
- Termination Date
- August 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390 prefilled syringes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: C274-000004678, BUD: 09/20/18