D-1325-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 17, 2022
- Initiation Date
- June 29, 2022
- Termination Date
- February 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 cartons
Product Description
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
Reason for Recall
CGMP Deviations: products were stored outside the drug label specifications.
Distribution Pattern
Nationwide in the USA.