Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
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 Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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