Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance
METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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 Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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