FDA Recall D-0910-2018
Fagron Compounding Services LLC dba Fagron Sterile Services · Wichita, KS
Class I — life-threatening Terminated 794 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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.
Recall record
- Recall number
D-0910-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-06-29
- Classified by FDA Center
- 2018-07-06
- FDA published
- 2018-07-11
- Terminated
- 2020-08-31
- Recalling firm
- Fagron Compounding Services LLC dba Fagron Sterile Services
- Firm location
- Wichita, KS