Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Incorrect labeling: Incorrect or missing lot and/or exp date
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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.
Compare with the code on your package — it is the most precise check available.
Drug: Succinylcholine
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility:
Lack of Assurance of Sterility; bags have potential to leak
Lack of Assurance of Sterility; bags have potential to leak
GMP Deviations: potential glass contamination
GMP Deviations: potential glass contamination
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