Class III · Low risk Ongoing
Methadone Hydrochloride Tablets
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Methadone HCl Injection 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
Methadone HCl Injection 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-0466-2018
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 Methadone recalls
See all
Class II · Moderate risk Terminated
Methadone
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
Methadone HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Methadone Hydrochloride Oral Concentrate
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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