# FDA recall D-0579-2016

> **Grato Holdings, Inc.** · Class II · drug recall initiated 2015-12-22.

## Product

Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

## Reason for recall

Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

## Distribution

Nationwide and to Guatemala and Canada.

## Key facts

- **Recall number:** D-0579-2016
- **Recalling firm:** Grato Holdings, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-12-22
- **Report date:** 2016-01-27
- **Termination date:** 2017-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woodbine, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0579-2016

## Citation

> AI Analytics. FDA recall D-0579-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0579-2016. Source: US FDA. Licensed CC0.

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