Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 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 Lack of Assurance of Sterility
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
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