0.2% ROPivacaine recall: Sterility Concern
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…
Why was 0.2% ROPivacaine recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 5/14/18 0722 47-00287Y EXP 06/28/2018
- Product
- 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…
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Quantity
- 20 bags
- Distribution
- Nationwide in the USA
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)