D-1545-2014 Class II Terminated
FDA drug recall D-1545-2014 was initiated by Fresenius Kabi USA, LLC on Aug 13, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 24, 2016). Affected quantity: 56,060 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 27, 2014
- Initiation Date
- Aug 13, 2014
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,060 vials
Product Description
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 6007698, Exp. 03/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1545-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026