Impax Laboratories recalls
Impax Laboratories appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2016-12-28.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2016-04-20 to 2016-12-28 |
| By agency | FDA Drug (5) |
| By classification | Class II (2), Class III (2), Class I (1) |
| By status | terminated (5) |
| Distribution named in notices | US |
Recalls
- Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson…
FDA Drug · Class I · 2016-12-28 · Impax Laboratories
Reason: Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs - Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 088…
FDA Drug · Class II · 2016-04-27 · Impax Laboratories
Reason: Failed Impurities/Degradation Specifications - Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08…
FDA Drug · Class II · 2016-04-27 · Impax Laboratories
Reason: Failed Impurities/Degradation Specifications - Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
FDA Drug · Class III · 2016-04-20 · Impax Laboratories
Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date - Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
FDA Drug · Class III · 2016-04-20 · Impax Laboratories
Reason: Labeling: Incorrect or Missing Lot and/or Exp. Date