# FDA recall D-0355-2016

> **Downing Labs, LLC** · Class II · drug recall initiated 2015-10-16.

## Product

HCG (Lyophilized) Injectable, 5000 units/vial,  5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

## Reason for recall

Lack of Assurance of Sterility

## Distribution

Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

## Key facts

- **Recall number:** D-0355-2016
- **Recalling firm:** Downing Labs, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-16
- **Report date:** 2015-11-25
- **Termination date:** 2016-09-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dallas, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2016

## Citation

> AI Analytics. FDA recall D-0355-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0355-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*