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
Reported: July 25, 2018 Initiated: June 12, 2018 #D-0942-2018
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Details
- Recalling Firm
- Avella of Deer Valley, Inc. Store 38
- Units Affected
- 20 bags
- Distribution
- Nationwide in the USA
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Avella of Deer Valley, Inc. Store 38. Units affected: 20 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential leakage of bags.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 25, 2018. Severity: Moderate. Recall number: D-0942-2018.
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