FDAFDA · Food and drugs·Recall number D-0942-2018
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP QS 250 mL). Volume 250 mL. Single dose Cassette. For: Parkland Memorial Hospital. By: Advanced Pharma, 9225 Kirby Dr. Houston, TX 77054. Parkland Memorial Hospital NDC 15082-002-87
Published July 25, 2018 · Recall initiated: June 12, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Potential leakage of bags.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Avella of Deer Valley, Inc. Store 38
- Distributor
- Nationwide in the USA
- Lot
- Lot 5/14/18 0722 47-00287Y EXP 06/28/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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