Recalls / Class III
Class IIID-0154-2020
Product
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
- Affected lot / code info
- Lots: SU9079A, SU9079B, Exp 4/5/2020
Why it was recalled
Incorrect labeling: Incorrect or missing lot and/or exp date
Recalling firm
- Firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 19,390 syringes
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-10-21
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0154-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.