Class II · Moderate riskTerminated Initiated Jul 24, 2019 (7 years ago)
C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
What was recalled
C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Recalling firm
Colonia Care Pharmacy
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0009-2020
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…