https://www.drugs.com/fda_alerts.html FDA MedWatch Alerts from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals. en https://www.drugs.com/fda/legacy-pharmaceutical-packaging-llc-issues-voluntary-nationwide-recall-losartan-potassium-usp-25mg-14253.html?utm_source=ddc&utm_medium=rss&utm_campaign=Legacy+Pharmaceutical+Packaging%2C+LLC+Issues+Voluntary+Nationwide+Recall+of+Losartan+Potassium+Tablets%2C+USP%2C+25mg%2C+50mg%2C+And+100mg+Due+to+The+Detection+of+Trace+Amounts+Of+N-Nitroso+N-Methyl+4-Amino+Butyric+Acid+%28NMBA%29+Impurity+Found+in+The+Active+Pharmaceutical+Ingredient+%28API%29 Audience: Consumer, Health Professional, Pharmacy Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber... Fri, 15 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/stokes-healthcare-inc-issues-voluntary-nationwide-recall-pilocarpine-0-1-ophthalmic-solution-due-14252.html?utm_source=ddc&utm_medium=rss&utm_campaign=Stokes+Healthcare+Inc.+Issues+Voluntary+Nationwide+Recall+of+Pilocarpine+0.1%25+Ophthalmic+Solution+Due+to+a+High+Level+of+Preservative Audience: Consumer, Health Professional, Pharmacy Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to... Wed, 13 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/american-health-packaging-issues-voluntary-nationwide-recall-valsartan-due-detection-ndea-n-14251.html?utm_source=ddc&utm_medium=rss&utm_campaign=American+Health+Packaging+Issues+Voluntary+Nationwide+Recall+of+Valsartan+Tablets+Due+to+the+Detection+of+NDEA+%28N-Nitrosodiethylamine%29+Impurity Audience: Consumer, Health Professional, Pharmacy American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the... Thu, 07 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/apotex-corp-issues-voluntary-nationwide-recall-drospirenone-ethinyl-estradiol-usp-28x3-blister-pack-14250.html?utm_source=ddc&utm_medium=rss&utm_campaign=Apotex+Corp.+Issues+Voluntary+Nationwide+Recall+of+Drospirenone+and+Ethinyl+Estradiol+Tablets%2C+USP%2C+28x3+Blister+Pack%2FCarton+Due+to+Possibility+of+Missing%2FIncorrect+Tablet+Arrangement Audience: Consumer, Health Professional, Pharmacy Weston, Florida, Apotex Corp . is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl... Mon, 04 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/updated-torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-losartan-potassium-usp-14249.html?utm_source=ddc&utm_medium=rss&utm_campaign=Updated%3A+Torrent+Pharmaceuticals+Limited+Issues+Voluntary+Nationwide+Recall+of+Losartan+Potassium+Tablets%2C+USP+and+Losartan+Potassium+%2FHydrochlorothiazide+Tablets%2C+USP Audience: Consumer, Health Professional, Pharmacy Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to... Fri, 01 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/aurobindopharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-expansion-38-lots-14248.html?utm_source=ddc&utm_medium=rss&utm_campaign=AurobindoPharma+USA%2C+Inc.+Initiates+a+Voluntary+Nationwide+Consumer+Level+Recall+Expansion+of+38+Lots+of+Amlodipine%2FValsartan+Tablets+USP+and+Valsartan+Tablets%2C+USP+Due+to+the+Detection+of+NDEA+Impurity Audience: Consumer, Health Professional, Pharmacy AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan, and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an... Fri, 01 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/fda-updates-angiotensin-ii-receptor-blocker-arb-recalls-14201.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Updates+on+Angiotensin+II+Receptor+Blocker+%28ARB%29+Recalls Audience: Consumer, Health Professional, Pharmacy Investigation ongoing – This page to be updated as more information is available IMPORTANT: Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled.... Fri, 01 Mar 2019 00:00:00 GMT https://www.drugs.com/fda/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-losartan-potassium-usp-25-mg-50-mg-14246.html?utm_source=ddc&utm_medium=rss&utm_campaign=Camber+Pharmaceuticals%2C+Inc.+Issues+Voluntary+Nationwide+Recall+of+Losartan+Potassium+Tablets%2C+USP%2C+25+mg%2C+50+mg+and+100+mg+Due+to+the+Detection+of+Trace+Amounts+of+NMBA+Impurity+found+in+the+Active+Pharmaceutical+Ingredient Audience: Consumer, Health Professional, Pharmacy Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso... Thu, 28 Feb 2019 00:00:00 GMT https://www.drugs.com/fda/safety-communication-xeljanz-xeljanz-xr-tofacitinib-safety-trial-finds-increased-risk-blood-clots-14247.html?utm_source=ddc&utm_medium=rss&utm_campaign=Safety+Communication%3A+Xeljanz%2C+Xeljanz+XR+%28tofacitinib%29+Safety+Trial+Finds+Increased+Risk+of+Blood+Clots+in+the+Lungs+and+Death+with+Higher+Dose+in+Rheumatoid+Arthritis+Patients Audience: Patient, Health Professional, Pharmacy, Rheumatology ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz,... Mon, 25 Feb 2019 00:00:00 GMT https://www.drugs.com/fda/golean-detox-usa-issues-voluntary-nationwide-recall-golean-detox-capsules-due-presence-undeclared-14245.html?utm_source=ddc&utm_medium=rss&utm_campaign=Golean+Detox+USA+Issues+Voluntary+Nationwide+Recall+of+Golean+DETOX+Capsules+Due+to+Presence+of+Undeclared+Sibutramine+and+Phenolphthalein Audience: Consumer, Health Professional, Pharmacy Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with... Mon, 25 Feb 2019 00:00:00 GMT https://www.drugs.com/fda/macleods-pharmaceuticals-limited-issues-voluntary-nationwide-consumer-level-recall-one-lot-losartan-14244.html?utm_source=ddc&utm_medium=rss&utm_campaign=Macleods+Pharmaceuticals+Limited+Issues+Voluntary+Nationwide+Consumer+Level+Recall+of+One+Lot+of+Losartan+Potassium%2FHydrochlorothiazide+Combination+Tablets+100mg%2F25mg+Due+to+detection+of+NDEA+Impurity Audience: Consumer, Health Professional, Pharmacy Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts... Fri, 22 Feb 2019 00:00:00 GMT https://www.drugs.com/fda/fda-adds-boxed-warning-increased-risk-death-gout-medicine-uloric-febuxostat-14243.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Adds+Boxed+Warning+for+Increased+Risk+of+Death+with+Gout+Medicine+Uloric+%28febuxostat%29 Audience: Consumer, Health Professional, Pharmacy This is an update to the FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric) issued on November... Thu, 21 Feb 2019 00:00:00 GMT https://www.drugs.com/fda/updated-torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-losartan-potassium-usp-14238.html?utm_source=ddc&utm_medium=rss&utm_campaign=UPDATED%3A+Torrent+Pharmaceuticals+Limited+Issues+Voluntary+Nationwide+Recall+of+Losartan+Potassium+Tablets%2C+USP+and+Losartan+Potassium+and+Hydrochlorothiazide+Tablets%2C+USP Audience: Consumer, Health Professional, Pharmacy. Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the... Tue, 22 Jan 2019 00:00:00 GMT https://www.drugs.com/fda/prinston-pharmaceutical-inc-issues-voluntary-nationwide-recall-irbesartan-irbesartan-hctz-due-14236.html?utm_source=ddc&utm_medium=rss&utm_campaign=Prinston+Pharmaceutical+Inc.+Issues+Voluntary+Nationwide+Recall+of+Irbesartan+and+Irbesartan+HCTZ+Tablets+Due+to+Detection+of+a+Trace+Amount+of+Unexpected+Impurity%2C+N-Nitrosodiethylamine+%28NDEA%29+in+the+Products Audience: Consumer, Health Professional, Pharmacy Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the... Fri, 18 Jan 2019 00:00:00 GMT https://www.drugs.com/fda/sun-pharmaceutical-industries-inc-issues-voluntary-nationwide-recall-vecuronium-bromide-due-14234.html?utm_source=ddc&utm_medium=rss&utm_campaign=Sun+Pharmaceutical+Industries%2C+Inc.+Issues+Voluntary+Nationwide+Recall+of+Vecuronium+Bromide+for+Injection+Due+to+the+Presence+of+Particulate+Matter+Identified+as+Glass Audience: Health Professional, Pharmacy Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder),... Tue, 08 Jan 2019 00:00:00 GMT https://www.drugs.com/fda/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-80-lots-amlodipine-14231.html?utm_source=ddc&utm_medium=rss&utm_campaign=Aurobindo+Pharma+USA%2C+Inc.+Initiates+Voluntary+Nationwide+Consumer+Level+Recall+of+80+Lots+of+Amlodipine+Valsartan+Tablets+USP%2C+Valsartan+HCTZ+Tablets%2C+USP+and+Valsartan+Tablets+USP%2C+Due+to+the+Detection+of+NDEA+%28N-Nitrosodiethylamine%29+Impurity Audience: Consumer, Health Professional, Pharmacy Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the... Mon, 31 Dec 2018 00:00:00 GMT https://www.drugs.com/fda/fluoroquinolone-antibiotics-safety-communication-increased-risk-ruptures-tears-aorta-blood-vessel-14227.html?utm_source=ddc&utm_medium=rss&utm_campaign=Fluoroquinolone+Antibiotics%3A+Safety+Communication+-+Increased+Risk+of+Ruptures+or+Tears+in+the+Aorta+Blood+Vessel+in+Certain+Patients Audience: Health Professional, Infectious Disease, Cardiology, Patient ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the... Thu, 20 Dec 2018 00:00:00 GMT https://www.drugs.com/fda/fda-alerts-health-care-professionals-patients-not-products-intended-sterile-promise-pharmacy-14225.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Alerts+Health+Care+Professionals+and+Patients+Not+to+Use+Drug+Products+Intended+to+be+Sterile+from+Promise+Pharmacy Audience: Consumer, Health Professional, Pharmacy The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room... Fri, 07 Dec 2018 15:00:00 GMT https://www.drugs.com/fda/tris-pharma-issues-voluntary-nationwide-recall-infants-ibuprofen-concentrated-oral-suspension-usp-14224.html?utm_source=ddc&utm_medium=rss&utm_campaign=Tris+Pharma+Issues+Voluntary+Nationwide+Recall+of+Infants%E2%80%99+Ibuprofen+Concentrated+Oral+Suspension%2C+USP+%28NSAID%29+50+mg+per+1.25+mL%2C+Due+to+Potential+Higher+Concentrations+of+Ibuprofen Audience: Consumer, Health Professional, Pharmacy December 5, 2018 -- Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled... Wed, 05 Dec 2018 00:00:00 GMT https://www.drugs.com/fda/fda-warns-serious-condition-affecting-blood-cells-not-being-recognized-leukemia-medicine-idhifa-14222.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Warns+That+Symptoms+of+a+Serious+Condition+Affecting+the+Blood+Cells+Are+Not+Being+Recognized+with+the+Leukemia+Medicine+Idhifa+%28enasidenib%29 Audience: Consumer, Health Professional, Pharmacy The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the... Thu, 29 Nov 2018 16:00:00 GMT