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Recall Observatory FDA recall evidence

Drug 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.

D-0154-2020

October 21, 2019

Class III

Product summary

Firm
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Event
Event 84106
Status
Terminated
Classification
Class III
Quantity
19,390 syringes
Official record key
drug-enforcement:D-0154-2020

Official wording

Reason: Incorrect labeling: Incorrect or missing lot and/or exp date

Code information: Lots: SU9079A, SU9079B, Exp 4/5/2020

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling: Incorrect or missing