Recalls / Class II
Class IID-1545-2014
Product
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
- Brand name
- Propranolol
- Generic name
- Propranolol Hydrochloride
- Active ingredient
- Propranolol Hydrochloride
- Route
- Intravenous
- NDC
- 63323-604
- FDA application
- ANDA075826
- Affected lot / code info
- Lot 6007698, Exp. 03/16
Why it was recalled
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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2045 Cornell Ave, Melrose Park, Illinois 60160-1002
Distribution
- Quantity
- 56,060 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-08-13
- FDA classified
- 2014-08-19
- Posted by FDA
- 2014-08-27
- Terminated
- 2016-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1545-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.