Class II · Moderate riskTerminated Initiated Jan 15, 2020 (7 years ago)
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0630-1
Recalling firm
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
NDC code
71283-0630-1
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0951-2020
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 Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were…