# FDA recall D-0608-2018

> **Paddock Laboratories, LLC.** · Class II · drug recall initiated 2018-02-26.

## Product

Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427.  NDC: 0574-2067-27

## Reason for recall

Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.

## Distribution

Nationwide within the USA.

## Key facts

- **Recall number:** D-0608-2018
- **Recalling firm:** Paddock Laboratories, LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-26
- **Report date:** 2018-04-04
- **Termination date:** 2020-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Hope, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2018

## Citation

> AI Analytics. FDA recall D-0608-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0608-2018. Source: US FDA. Licensed CC0.

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