Drug recall
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only…
FDA recall event 75083 · Class III · West-Ward Pharmaceuticals Corp.
Key facts
| Event ID | 75083 |
|---|---|
| Recall numbers | D-1515-2016 |
| Recalling firm | West-Ward Pharmaceuticals Corp. |
| Product type | Drugs |
| Products | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. |
| Initiation date | Aug 18, 2016 |
| Report date | Sep 28, 2016 |
| Termination date | Sep 1, 2017 |
| City | Eatontown |
| State | NJ |
| Country | United States |
| FEI number | 2250102 |
At a glance
- 1–9 Products in this recall
- 10–99 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: