Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot #: C274-000004678, BUD: 09/20/18
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0911-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 29, 2018
- FDA report date
- Jul 11, 2018
- Quantity
- 390 prefilled syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron Compounding Services LLC dba Fagron Sterile Services
Original FDA data
Every field from FDA enforcement report D-0911-2018, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 80383
- Address
- 8710 E 34th St N
- Code information
- Lot #: C274-000004678, BUD: 09/20/18
- Postal code
- 67226-2636
- Report date
- Jul 11, 2018
- Product type
- Drugs
- Recall number
- D-0911-2018
- Classification
- Class I
- Recalling firm
- Fagron Compounding Services LLC dba Fagron Sterile Services
- Product quantity
- 390 prefilled syringes
- Termination date
- Aug 31, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 29, 2018
- Center classification date
- Jul 6, 2018