ENDO USA, Inc. — Class II: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manuf
ENDO USA, Inc. has initiated a Class II recall for Buprenorphine Hydrochloride Injection (0.3mg/mL) due to the presence of particulate matter identified as Buprenorphine free base.
This affects ENDO USA, Inc., healthcare providers utilizing NDC 42023-179-05, and quality assurance and manufacturing departments involved in injectable drug production.
The presence of particulate matter in injectable products presents clinical risks and indicates potential failures in formulation stability or manufacturing controls. The identification of the particulate as the active ingredient's free base suggests a possible pH or solubility issue in the manufacturing process that may require technical remediation to ensure long-term product stability.
Quality units should evaluate incoming material certificates of analysis and manufacturing crystallization parameters to prevent free base precipitation. QA teams should also verify that internal inspection protocols are sufficient to detect internal particulate matter before distribution.
Class II. Reason: Presence of particulate matter: identified as Buprenorphine free base. Product: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.. Firm: ENDO USA, Inc. (Rochester MI United States). Status: Ongoing.
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