Class II · Moderate risk Ongoing
Labetalol Hydrochloride Injection
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Labetalol HCl in all strengths
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Labetalol HCl in all strengths, all doses, and all packaging.
- Recalling firm
- Pharmedium Services, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0447-2018
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.
Other Labetalol recalls
See all
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4mL Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk Terminated
PF-Labetalol HCl Injection
Reason CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk Terminated
Labetalol HCl Injection
Reason Lack of Assurance of Sterility
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