Class II · Moderate riskTerminated Initiated Jun 12, 2019 (7 years ago)
Dexamethasone 10 Mg / 50 Ml Ns Ivpb; Dexamethasone 5 Mg / 50 Ml Ns; Dexamethasone 5 Mg /…
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 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHASONE 5 MG / 50 ML NS IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Recalling firm
Infusion Options, Inc.
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1767-2019
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…