Drug recall
Cyclosporin 0.2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy…
FDA recall event 72501 · Class II · Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Key facts
| Event ID | 72501 |
|---|---|
| Recall numbers | V-394-2016, V-395-2016, V-396-2016, V-397-2016, V-398-2016, V-399-2016, V-400-2016 |
| Recalling firm | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma |
| Product type | Veterinary |
| Products | Cyclosporin 0.2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614, Cyclosporin 1% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614, Cyclosporin 2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614, Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution, packaged in 2.5 mL and 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614, Methocarbamol 100mg/mL Injection, packaged in 50 mL sterile glass vials, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614 and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is… |
| Initiation date | Sep 3, 2015 |
| Report date | Mar 16, 2016 |
| Termination date | Feb 6, 2018 |
| City | Peoria |
| State | IL |
| Country | United States |
| FEI number | 3011581046 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: