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Showing 2101–2120 of 3363 results

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BuPROPion Extended-release 150mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

FDAApr 8, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

BuPROPion Extended-release 100mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

FDAApr 8, 2016Nationwide

• Jubilant Cadista Pharmaceuticals, Inc.

BuPROPion Extended-release 200mg (Jubilant) – Impurity Specs (2016)

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

FDAApr 8, 2016Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Haloperidol Decanoate Injection (Fresenius) – Impurity Issue (2016)

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

FDAApr 7, 2016Nationwide• Fresenius Kabi USA, LLC

Lisinopril 40mg Tablets (Lupin) – CGMP Deviation (2016)

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

FDAApr 6, 2016IN• Lupin Pharmaceuticals Inc.

Lisinopril 30mg Tablets (Lupin) – CGMP Deviation (2016)

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

FDAApr 6, 2016IN• Lupin Pharmaceuticals Inc.

Lisinopril-HCTZ Tablets (Lupin) – CGMP Deviation (2016)

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

FDAApr 4, 2016Nationwide• Lupin Pharmaceuticals Inc.

Fenofibrate Capsules (Amerisource) – Labeling Issue (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAMar 31, 2016Nationwide• Amerisource Health Services

Intermezzo Sublingual Tablet (Purdue) – Dissolution Specs (2016)

Failed Dissolution Specifications

FDAMar 31, 2016FL, LA, MI +5 more• Purdue Pharma L.P.

Fenofibrate Capsules (Amerisource) – Missing Lot Information (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAMar 31, 2016Nationwide• Amerisource Health Services

Topicort Cream (Taro) – Subpotent Drug (2016)

Subpotent Drug

FDAMar 31, 2016CA, CT, MD +6 more• Taro Pharmaceuticals U.S.A., Inc.

Pistachio Orange Macaroons – Shell Fragment Risk (2016)

Manischewitz Pistachio Orange macaroons may contain pistachio shell fragments.

FDAMar 30, 2016CA, FL, IL +3 more• R.A.B. Food Group LLC

Venlafaxine 75mg Tablet (Bryant Ranch) – Labeling Mix-Up (2016)

Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.

FDAMar 25, 2016Nationwide• Bryant Ranch Prepack Inc.

Welltop Fried Dace (Strong America) – chemical contamination (2016)

FDA sampling discovered the presence of leucomalachite green

FDAMar 25, 2016NY• Strong America Limited

Simvastatin Tablets 5 mg (Biocon) – Subpotent Drug (2016)

Subpotent Drug

FDAMar 24, 2016CA, OH, PA• Biocon Inc

Zemplar Capsules 1 mcg (AbbVie) – Content Uniformity Issue (2016)

Failed Content Uniformity Specifications

FDAMar 24, 2016Nationwide• AbbVie Inc.

Escitalopram Tablets 20 mg (Lupin) – Incorrect Labeling (2016)

Labeling: Incorrect or Missing Lot and/or Expiration Date

FDAMar 24, 2016Nationwide• Lupin Limited

Magnesium Sulfate Injection (Hospira) – pH Specification Failure (2016)

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

FDAMar 23, 2016Nationwide• Hospira Inc.

Fenofibrate 200mg Capsules (Impax) – Labeling Error (2016)

Labeling: Incorrect or Missing Lot and/or Exp. Date

FDAMar 17, 2016Nationwide• Impax Laboratories, Inc.

Fenofibrate 134mg Capsules (Impax) – Labeling Error (2016)

Labeling: Incorrect or Missing Lot and/or Exp. Date

FDAMar 17, 2016Nationwide• Impax Laboratories, Inc.

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