Ropivacaine HCl 0.2% in recall: Sterility Concern
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100…
Why was Ropivacaine HCl 0.2% in recalled?
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
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 #: 151900249M, Exp 09/09/15
- Product
- Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 120 cassettes
- Distribution
- VA, IL, PA, ID
- Recall date
- September 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)