Why it was recalled
Lack of sterility assurance.
Product description
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Lot numbers, UPCs & expiration codes
Lots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
Where it was sold
NC
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-1240-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2019
- FDA report date
- May 1, 2019
- Quantity
- 110 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CMC Enterprise Pharmacy
Original FDA data
Every field from FDA enforcement report D-1240-2019, exactly as published.
Show all FDA fields
- City
- Charlotte
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 82620
- Address
- 4400 Golf Acres Dr
- Code information
- Lots: ED041909 Exp. 4/13/2019; ED111907 Exp. 4/20/2019
- Postal code
- 28208-5968
- Report date
- May 1, 2019
- Product type
- Drugs
- Recall number
- D-1240-2019
- Classification
- Class II
- Recalling firm
- CMC Enterprise Pharmacy
- Product quantity
- 110 bags
- Termination date
- Oct 30, 2019
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Distribution pattern
- NC
- Recall initiation date
- Apr 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2019