Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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