FDAFDA · Food and drugs·Recall number D-1545-2014
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Published August 27, 2014 · Recall initiated: August 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROPRANOLOL
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0363323604004
- Lot
- Lot 6007698, Exp. 03/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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