HCG 1000 Units/mL SUB-Q Injection — Class II drug recall D-306-2016
Terminated recall by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma, reported 2015-11-25, distributed nationwide. Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiat
| Recall number | D-306-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma, Peoria, IL, United States |
| Recall initiated | 2015-09-03 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-12-29 |
| Distributed | Nationwide (US) |
| Quantity | 49 vials |
| Reason classes | sterility |
| Lot numbers | 080415, 080515, 080615, 080715, 081015, 081115, 081215, 081315, 081415, 1702-081715, 1702-081815, 1702-081915 |
| Expiration dates | 2015-09-04, 2015-09-05, 2015-09-06, 2015-09-07, 2015-09-10, 2015-09-11, 2015-09-12, 2015-09-13, 2015-09-14, 2015-09-17, 2015-09-18, 2015-09-19 |
Product
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-306-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.