# FDA recall D-1418-2019

> **Premier Pharmacy Labs Inc** · Class II · drug recall initiated 2019-06-18.

## Product

Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.

## Reason for recall

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1418-2019
- **Recalling firm:** Premier Pharmacy Labs Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-06-18
- **Report date:** 2019-07-03
- **Termination date:** 2021-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Weeki Wachee, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1418-2019

## Citation

> AI Analytics. FDA recall D-1418-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1418-2019. Source: US FDA. Licensed CC0.

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