Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Succinylcholine Chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Drug: Succinylcholine
- Recalling firm
- Fagron Compounding Services LLC dba Fagron Sterile Services
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0946-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Succinylcholine recalls
See all
Class II · Moderate risk
Succinylcholine Chloride Injection
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
SUCcinylcholine Chloride 200 mg/10mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
succinylcholine
Lack of assurance of sterility:
Other recalls by Fagron Compounding Services LLC dba Fagron Sterile Services
All 2017 recalls
Class II · Moderate risk
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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