Recalls / Class II
Class IID-0423-2018
Product
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
- Affected lot / code info
- Lot #: 180030029D, Exp 2/18/18
Why it was 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.
Recalling firm
- Firm
- PharMEDium Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 36 Stults Rd, Dayton, New Jersey 08810
Distribution
- Quantity
- 21 Cassettes
- Distribution pattern
- Product was distributed to SC, FL, NY, NY,WA
Timeline
- Recall initiated
- 2018-02-05
- FDA classified
- 2018-03-29
- Posted by FDA
- 2018-02-21
- Terminated
- 2018-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0423-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.