Actavis Elizabeth recalls
Actavis Elizabeth appears in 14 official U.S. recall notices indexed by RecallRadar, most recently on 2016-11-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 14 |
|---|---|
| Published | 2013-03-13 to 2016-11-30 |
| By agency | FDA Drug (14) |
| By classification | Class II (12), Class III (2) |
| By status | terminated (14) |
| Distribution named in notices | PR, US |
Recalls
- NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Eliza…
FDA Drug · Class III · 2016-11-30 · Actavis Elizabeth
Reason: Presence of Foreign Tablets/Capsules - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx O…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx…
FDA Drug · Class II · 2016-04-13 · Actavis Elizabeth
Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities. - Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, N…
FDA Drug · Class II · 2015-03-11 · Actavis Elizabeth
Reason: Failed Dissolution Specifications - Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manu…
FDA Drug · Class II · 2015-01-14 · Actavis Elizabeth
Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distributi… - Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt
FDA Drug · Class II · 2015-01-14 · Actavis Elizabeth
Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distributi… - Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manu…
FDA Drug · Class II · 2015-01-14 · Actavis Elizabeth
Reason: Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distributi… - Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 0720…
FDA Drug · Class II · 2014-03-19 · Actavis Elizabeth
Reason: Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. - Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Av…
FDA Drug · Class II · 2014-03-12 · Actavis Elizabeth
Reason: Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. - Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11…
FDA Drug · Class II · 2014-03-05 · Actavis Elizabeth
Reason: Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. - Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-402…
FDA Drug · Class II · 2013-12-04 · Actavis Elizabeth
Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets - Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules,…
FDA Drug · Class III · 2013-03-13 · Actavis Elizabeth
Reason: Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.