Recall archive
163 recalls · page 5 of 7
Reported Mar 15, 2017
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
FDA (openFDA drug enforcement)
Reported Feb 22, 2017
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
FDA (openFDA drug enforcement)
Reported Feb 1, 2017
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Subpotency: due to a low, out of specification test result for assay during stability testing.
FDA (openFDA drug enforcement)
Reported Jan 25, 2017
Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Dec 14, 2016
Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 26, 2016
PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 19, 2016
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — CGMP Deviations
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 12, 2016
Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva North America
Matched: Brand · Product details — Failed Impurities/Degradation Specifications.
FDA (openFDA drug enforcement)
Reported Sep 14, 2016
ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva North America
Matched: Brand · Product · Product details — CGMP Deviations
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 17, 2016
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva North America
Matched: Brand · Product · Product details — Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
FDA (openFDA drug enforcement)
Reported Aug 3, 2016
Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva North America
Matched: Brand · Product · Product details — Failed Tablet/Capsule Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 1, 2016
Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva North America
Matched: Brand · Product details — Lack of Assurance of Sterility: Due to potential for leaking bags.
FDA (openFDA drug enforcement)
Reported Jun 1, 2016
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Presence of Particulate Matter: particulate matter identified as glass in one vial.
FDA (openFDA drug enforcement)
Reported May 11, 2016
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Bryant Ranch Prepack Inc.
Matched: Product details · Reason for recall — Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as…
FDA (openFDA drug enforcement)
Reported Mar 23, 2016
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 9, 2016
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva North America
Matched: Brand · Product details — Failed Dissolution Specifications: low test results at the 18 month time-point
FDA (openFDA drug enforcement)
Reported Jan 20, 2016
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
FDA (openFDA drug enforcement)
Reported Sep 23, 2015
ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.EMD Serono, Inc.
Matched: Product details — Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
FDA (openFDA drug enforcement)
Reported Sep 2, 2015
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA
Matched: Brand · Product details — Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
FDA (openFDA drug enforcement)
Reported Aug 12, 2015
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: out of specification for unknown impurity
FDA (openFDA drug enforcement)
Reported Jul 15, 2015
Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teva Pharmaceuticals USA
Matched: Brand · Product details — Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and…
FDA (openFDA drug enforcement)
Reported Jun 17, 2015
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Valeant Pharmaceuticals North America LLC
Matched: Brand · Product · Product details — Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
FDA (openFDA drug enforcement)
Reported Jun 10, 2015
Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA
Matched: Brand · Product · Product details — Failed Dissolution Specifications: OOS result during stability testing
FDA (openFDA drug enforcement)
Reported Jun 3, 2015
QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
FDA (openFDA drug enforcement)
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