Impax Laboratories, Inc.
Impax Laboratories, Inc. appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 14 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0215-2017, Class I) was initiated on August 19, 2016.
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 14
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0215-2017 | Class I | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets | August 19, 2016 |
| D-0820-2016 | Class III | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, | March 17, 2016 |
| D-0821-2016 | Class III | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, | March 17, 2016 |
| D-0826-2016 | Class II | Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed | March 14, 2016 |
| D-0825-2016 | Class II | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distribute | March 14, 2016 |