# FDA recall D-311-2016

> **Kalman Health & Wellness, Inc. dba Essential Wellness Pharma** · Class II · drug recall initiated 2015-09-03.

## Product

HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

## Reason for recall

Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-311-2016
- **Recalling firm:** Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-03
- **Report date:** 2015-11-25
- **Termination date:** 2017-12-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-311-2016

## Citation

> AI Analytics. FDA recall D-311-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-311-2016. Source: US FDA. Licensed CC0.

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