PROPRANOLOL HYDROCHLORIDE INJECTION — Class II drug recall D-1545-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2014-08-27, distributed nationwide. CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical defici
| Recall number | D-1545-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Melrose Park, IL, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-08-19 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2016-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 56,060 vials |
| Reason classes | cgmp |
| NDC | 63323-0604, 63323-0604-01 |
| Lot numbers | 03/16, 6007698 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1545-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.