FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b)…

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

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-317-60 D-0671-2017

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b)…

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

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-316-60 D-0670-2017

Class III · Low risk Terminated Apr 8, 2016

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b)…

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

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-315-60 D-0669-2017

Class III · Low risk Terminated Apr 7, 2016

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

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

Fresenius Kabi USA, LLC NDC 63323-469-01 D-0818-2016

Class III · Low risk Terminated Apr 6, 2016

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202…

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

Lupin Pharmaceuticals Inc. NDC 68180-517-03 D-1503-2016

Class III · Low risk Terminated Apr 6, 2016

Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01)…

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

Lupin Pharmaceuticals Inc. NDC 68180-516-02 D-1502-2016

Class III · Low risk Terminated Apr 4, 2016

Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only…

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

Lupin Pharmaceuticals Inc. NDC 68180-519-01 D-1052-2016

Class III · Low risk Terminated Mar 31, 2016

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro…

Reason Subpotent Drug

Taro Pharmaceuticals U.S.A., Inc. D-0950-2016

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by…

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

Amerisource Health Services NDC 68084-835-32 D-0823-2016

Class III · Low risk Terminated Mar 31, 2016

Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and…

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

Amerisource Health Services NDC 68084-835-32 D-0822-2016

Class III · Low risk Terminated Mar 31, 2016

Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT…

Reason Failed Dissolution Specifications

Purdue Pharma L.P. D-0810-2016

Class III · Low risk Terminated Mar 25, 2016

Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC…

Reason Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as…

Bryant Ranch Prepack Inc. NDC 63629-3324-6 D-0837-2016

Class III · Low risk Terminated Mar 24, 2016

Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202…

Reason Labeling: Incorrect or Missing Lot and/or Expiration Date

Lupin Limited NDC 68180-136-01 D-1516-201

Class III · Low risk Terminated Mar 24, 2016

Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.

Reason Failed Content Uniformity Specifications

AbbVie Inc. NDC 0074-4317-30 D-0833-2016

Class III · Low risk Terminated Mar 24, 2016

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles…

Reason Subpotent Drug

Biocon Inc NDC 24658-0300-90 D-0817-2016

Class III · Low risk Ongoing Mar 23, 2016

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per…

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

Hospira Inc. NDC 0409-2168-02 D-0854-2016

Class III · Low risk Terminated Mar 17, 2016

Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…

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

Impax Laboratories, Inc. NDC 0115-0533-02 D-0821-2016

Class III · Low risk Terminated Mar 17, 2016

Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…

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

Impax Laboratories, Inc. NDC 0115-0522-02 D-0820-2016

Class III · Low risk Terminated Mar 16, 2016

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For…

Reason Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or…

Actavis Pharma Inc D-1060-2016

Class III · Low risk Ongoing Mar 15, 2016

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label…

Hospira Inc. NDC 0409-6629-02 D-0836-2016

Class III · Low risk Terminated Mar 11, 2016

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1…

Reason CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.

Lupin Pharmaceuticals Inc. D-0955-2016

Class III · Low risk Terminated Mar 11, 2016

Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx…

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

Lupin Pharmaceuticals Inc. NDC 68180-644-01 D-0954-2016

Class III · Low risk Terminated Mar 11, 2016

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx…

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

Lupin Pharmaceuticals Inc. NDC 68180-633-01 D-0953-2016

Class III · Low risk Terminated Mar 11, 2016

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count…

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

Lupin Pharmaceuticals Inc. NDC 68180-622-01 D-0952-2016

Class III · Low risk Terminated Mar 11, 2016

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count…

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

Lupin Pharmaceuticals Inc. NDC 68180-611-01 D-0951-2016