0.2% Ropivacaine HCI recall: Endotoxin
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Why was 0.2% Ropivacaine HCI recalled?
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
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 #: 180030029D, Exp 2/18/18
- Product
- 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
- Recalling firm
- PharMEDium Services, LLC
- Quantity
- 21 Cassettes
- Distribution
- Product was distributed to SC, FL, NY, NY,WA
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)