Recalls / Class III
Class IIID-0931-2017
Product
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
- Affected lot / code info
- Lot: 170340167s; Exp. 01/01/1900
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Pharmedium Services Llc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr, N/A, Lake Forest, Illinois 60045-4847
Distribution
- Quantity
- 22 I.V. pumps
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-15
- FDA classified
- 2017-07-02
- Posted by FDA
- 2017-07-12
- Terminated
- 2020-01-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0931-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.