D-0809-2023 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2023
- Initiation Date
- April 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
All Lots