Drug recall
Amino Acid Cervical Cream, ACTIVE INGREDIENTS: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine 0.35%…
FDA recall event 33968 · Class II · Hope Medical Enterprises Inc
Key facts
| Event ID | 33968 |
|---|---|
| Recall numbers | D-024-6 |
| Recalling firm | Hope Medical Enterprises Inc |
| Product type | Drugs |
| Products | Amino Acid Cervical Cream, ACTIVE INGREDIENTS: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine 0.35%, Net Wt. 2 3/4 Ounce Tube 77.96 Grams & Applicator, Rx only, Manufactured by Sheffield… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Method validation deviations for finished product testing |
| Initiation date | Nov 3, 2005 |
| Termination date | Mar 7, 2012 |
| City | Scottsdale |
| State | AZ |
| Country | United States |
| FEI number | 3000255904 |
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