Recalls / Class II
Class IID-0333-2019
Product
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
- Affected lot / code info
- Lot: 183220013C Exp. 12/19/2018
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 50 ml in 60 ml syringes
- 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-0333-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.