FDA Drug recall D-304-2016
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. Universit…
- FDA Drug
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. Universit… by Kalman Health And Wellness, citing 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 practi….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-304-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-03 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Kalman Health And Wellness |
| Distribution | US |
Product
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Reason
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.
Identifiers
| code_info | Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/1…Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; 073015, Exp 10/30/2015; and 080615, Exp 11/08/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-304-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.