Class II · Moderate riskTerminated Initiated Apr 2, 2019 (7 years ago)
Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
Recalling firm
Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
Origin
TN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1141-2019
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…