# FDA recall D-1545-2014

> **Fresenius Kabi USA, LLC** · Class II · drug recall initiated 2014-08-13.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1545-2014
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-08-13
- **Report date:** 2014-08-27
- **Termination date:** 2016-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Melrose Park, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2014

## Citation

> AI Analytics. FDA recall D-1545-2014. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1545-2014. Source: US FDA. Licensed CC0.

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