Why it was recalled
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Product description
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Lot numbers, UPCs & expiration codes
Lot #: C926923, Exp 01/16
Where it was sold
Nationwide
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-1413-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2014
- FDA report date
- Jul 9, 2014
- Quantity
- 20,810 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1413-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68577
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: C926923, Exp 01/16
- Postal code
- 60015-4625
- Report date
- Jul 9, 2014
- Product type
- Drugs
- Recall number
- D-1413-2014
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 20,810 containers
- Termination date
- Apr 10, 2017
- Reason for recall
- Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 16, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 1, 2014