Recalls / Class II
Class IID-0334-2019
Product
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
- Affected lot / code info
- Lot: 183230004C Exp. 02/17/2019
Why it was recalled
Sub-potent
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 295 100 mL in 150 mL Intravia bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-12-05
- FDA classified
- 2018-12-15
- Posted by FDA
- 2018-12-26
- Terminated
- 2020-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0334-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.