Actavis Elizabeth LLC Recalls

All product recalls associated with Actavis Elizabeth LLC.

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Recall Summary

Total Recalls

14

Past Year

0

Class I (Serious)

0

Most Recent

Oct 2016

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–14 of 14 recalls

NIFEdipine Capsules (Actavis) – Foreign Tablets (2016)

Presence of Foreign Tablets/Capsules

Class IIILow

FDAOct 6, 2016Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class IIModerate

FDAFeb 16, 2016Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Saccharate (Actavis) – Impurity Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class II

Moderate

FDAFeb 16, 2016Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class IIModerate

FDAFeb 16, 2016Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class IIModerate

FDAFeb 16, 2016Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Capsules (Actavis) – Failed Dissolution (2015)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 10, 2015Nationwide• Actavis Elizabeth LLC

Gabapentin Capsules 100mg (Actavis) - Capsule Defect (2014)

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 distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

Gabapentin Capsules 300mg (Actavis) - Capsule Defect (2014)

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 distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

Gabapentin Capsules 400mg (Actavis) - Capsule Defect (2014)

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 distribution center.

Class IIModerate

FDADec 15, 2014PR• Actavis Elizabeth LLC

Alprazolam Tablets (Actavis) – Tablet Erosion Issue (2014)

Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Class IIModerate

FDAFeb 10, 2014Nationwide• Actavis Elizabeth LLC

Alprazolam Extended-Release Tablets (Actavis) – Dissolution Failure (2014)

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

Class IIModerate

FDAFeb 4, 2014Nationwide• Actavis Elizabeth LLC

Clonazepam Tablets (Actavis) – subpotent drug (2013)

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Class IIModerate

FDANov 6, 2013Nationwide• Actavis Elizabeth LLC

Alprazolam Tablets (Actavis) – Tablet Weight Deviation (2013)

Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets

Class IIModerate

FDAOct 9, 2013Nationwide• Actavis Elizabeth LLC

Dextroamphetamine Tablets (Actavis) – Failed Dissolution (2013)

Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.

Class IIILow

FDAFeb 13, 2013Nationwide• Actavis Elizabeth LLC

Stay Informed

Actavis Elizabeth LLC Recalls

Recall Summary

NIFEdipine Capsules (Actavis) – Foreign Tablets (2016)

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Dextroamphetamine Saccharate (Actavis) – Impurity Failure (2016)

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Dextroamphetamine Saccharate (Actavis) – Impurity Specification Failure (2016)

Dextroamphetamine Capsules (Actavis) – Failed Dissolution (2015)

Gabapentin Capsules 100mg (Actavis) - Capsule Defect (2014)

Gabapentin Capsules 300mg (Actavis) - Capsule Defect (2014)

Gabapentin Capsules 400mg (Actavis) - Capsule Defect (2014)

Alprazolam Tablets (Actavis) – Tablet Erosion Issue (2014)

Alprazolam Extended-Release Tablets (Actavis) – Dissolution Failure (2014)

Clonazepam Tablets (Actavis) – subpotent drug (2013)

Alprazolam Tablets (Actavis) – Tablet Weight Deviation (2013)

Dextroamphetamine Tablets (Actavis) – Failed Dissolution (2013)