Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc…
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
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 Lack of sterility assurance.
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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