Why it was recalled
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Product description
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Lot numbers, UPCs & expiration codes
Lot: 6400048
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-0152-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 27, 2017
- FDA report date
- Jan 10, 2018
- Quantity
- 203136 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0152-2018, exactly as published.
Show all FDA fields
- City
- Wilson
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 78396
- Address
- 5200 Corporate Pkwy
- Code information
- Lot: 6400048
- Postal code
- 27893-9412
- Report date
- Jan 10, 2018
- Product type
- Drugs
- Recall number
- D-0152-2018
- Classification
- Class I
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 203136 syringes
- Termination date
- Oct 5, 2020
- Reason for recall
- Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 27, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 4, 2018