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/fda-updates-vinca-alkaloid-labeling-preparation-intravenous-infusion-bags-only-14422.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Updates+Vinca+Alkaloid+Labeling+for+Preparation+in+Intravenous+Infusion+Bags+Only Audience: Health Care Professionals January 15, 2021 -- The U.S. Food and Drug Administration is alerting health care professionals to labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes... Fri, 15 Jan 2021 14:47:00 GMT https://www.drugs.com/fda/fresenius-kabi-issues-voluntary-nationwide-recall-ketorolac-tromethamine-usp-due-presence-14421.html?utm_source=ddc&utm_medium=rss&utm_campaign=Fresenius+Kabi+Issues+Voluntary+Nationwide+Recall+of+Ketorolac+Tromethamine+Injection++USP+Due+to+the+Presence+of+Particulate+Matter Audience: Consumer, Patient, Health Professional, Pharmacy January 08, 2021 -- Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the... Fri, 08 Jan 2021 11:23:00 GMT https://www.drugs.com/fda/essaar-inc-issues-voluntary-nationwide-recall-rubbing-alcohol-contaminated-methanol-14420.html?utm_source=ddc&utm_medium=rss&utm_campaign=Essaar+Inc++Issues+Voluntary+Nationwide+Recall+of+Rubbing+Alcohol+Contaminated+with+Methanol Audience: Consumer January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with... Mon, 04 Jan 2021 11:58:00 GMT https://www.drugs.com/fda/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-usp-750-14419.html?utm_source=ddc&utm_medium=rss&utm_campaign=Nostrum+Laboratories++Inc++Expands+Voluntary+Nationwide+Recall+of+Metformin+HCl+Extended+Release+Tablets++USP+750+mg++Due+to+N+Nitrosodimethylamine++NDMA++Content+Above+the+Acceptable+Daily+Intake++ADI++Limit Audience: Consumer, Patient, Health Professional, Pharmacy January 4, 2021 -- Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the... Mon, 04 Jan 2021 10:40:00 GMT https://www.drugs.com/fda/precision-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp-0-12-14418.html?utm_source=ddc&utm_medium=rss&utm_campaign=Precision+Dose++Inc++Issues+Voluntary+Nationwide+Recall+of+Paroex+Chlorhexidine+Gluconate+Oral+Rinse+USP++0+12+++15mL+Due+to+Microbial+Contamination Audience: Consumer, Patient, Health Professional, Pharmacy December 31, 2020 Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021... Thu, 31 Dec 2020 09:51:00 GMT https://www.drugs.com/fda/sunstar-americas-inc-expands-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-14417.html?utm_source=ddc&utm_medium=rss&utm_campaign=Sunstar+Americas+Inc++Expands+Voluntary+Nationwide+Recall+of+Paroex+++Chlorhexidine+Gluconate+Oral+Rinse+USP++0+12++Due+to+Microbial+Contamination Audience: Consumer, Patient, Health Professional, Pharmacy December 28, 2020 -- Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date... Mon, 28 Dec 2020 11:38:00 GMT https://www.drugs.com/fda/shane-erickson-inc-dba-innovative-marketing-consultants-issues-voluntary-nationwide-recall-wash-14416.html?utm_source=ddc&utm_medium=rss&utm_campaign=Shane+Erickson++Inc++DBA+Innovative+Marketing+Consultants+Issues+Voluntary+Nationwide+Recall+of+Wash+Free+Hand+Sanitizer+Due+to+Potential+Presence+of+Undeclared+Methanol Audience: Consumers December 23, 2020 -- Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and... Wed, 23 Dec 2020 09:48:00 GMT https://www.drugs.com/fda/avkare-issues-voluntary-nationwide-recall-sildenafil-100mg-trazodone-100mg-due-product-mix-up-14415.html?utm_source=ddc&utm_medium=rss&utm_campaign=AvKARE+Issues+Voluntary+Nationwide+Recall+of+Sildenafil+100mg+Tablets+and+Trazodone+100mg+Tablets+Due+to+Product+Mix+Up Audience: Consumer, Health Professional, Pharmacy December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled... Wed, 09 Dec 2020 12:09:00 GMT https://www.drugs.com/fda/torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-anagrelide-capsules-usp-due-14414.html?utm_source=ddc&utm_medium=rss&utm_campaign=Torrent+Pharmaceuticals+Limited+Issues+Voluntary+Nationwide+Recall+of+Anagrelide+Capsules++USP+Due+to+Dissolution+Test+Failure Audience: Consumer, Health Professional, Pharmacy December 9, 2020 -- Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality... Wed, 09 Dec 2020 11:58:00 GMT https://www.drugs.com/fda/fda-alerts-healthcare-professionals-risk-errors-tranexamic-acid-resulting-inadvertent-intrathecal-14413.html?utm_source=ddc&utm_medium=rss&utm_campaign=FDA+Alerts+Healthcare+Professionals+About+the+Risk+of+Medication+Errors+with+Tranexamic+Acid+Injection+Resulting+in+Inadvertent+Intrathecal++Spinal++Injection Audience: Healthcare Professionals December 3, 2020 -- The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of tranexamic acid injection. Intrathecal administration of... Thu, 03 Dec 2020 16:42:00 GMT https://www.drugs.com/fda/mpm-medical-llc-issues-voluntary-nationwide-recall-regenecare-ha-hydrogel-due-burkholderia-cepecia-14412.html?utm_source=ddc&utm_medium=rss&utm_campaign=MPM+Medical+LLC+Issues+Voluntary+Nationwide+Recall+of+Regenecare+HA+Hydrogel+Due+to+Burkholderia+cepecia+Contamination Audience: Consumer, Patient, Health Professional, Pharmacy December 2, 2020 -- Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the... Wed, 02 Dec 2020 08:38:00 GMT https://www.drugs.com/fda/fresenius-kabi-issues-voluntary-nationwide-recall-single-lot-dexmedetomidine-hydrochloride-due-14411.html?utm_source=ddc&utm_medium=rss&utm_campaign=Fresenius+Kabi+Issues+Voluntary+Nationwide+Recall+of+a+Single+Lot+of+Dexmedetomidine+Hydrochloride+Injection+Due+to+Cross+Contamination+of+Lidocaine Audience: Consumer, Patient, Health Professional, Pharmacy November 19, 2020 -- Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial.... Thu, 19 Nov 2020 10:54:00 GMT https://www.drugs.com/fda/lohxa-llc-issues-voluntary-nationwide-recall-chlorhexidine-gluconate-oral-rinse-usp-0-12-due-14410.html?utm_source=ddc&utm_medium=rss&utm_campaign=Lohxa+LLC+Issues+Voluntary+Nationwide+Recall+of+Chlorhexidine+Gluconate+Oral+Rinse+USP++0+12++Due+to+Microbial+Contamination Audience: Consumer, Patient, Health Professional, Pharmacy November 09, 2020 -- Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21... Mon, 09 Nov 2020 11:29:00 GMT https://www.drugs.com/fda/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-usp-500-14409.html?utm_source=ddc&utm_medium=rss&utm_campaign=Nostrum+Laboratories++Inc++Issues+Voluntary+Nationwide+Recall+of+Metformin+HCl+Extended+Release+Tablets++USP+500+mg++Due+to+N+Nitrosodimethylamine++NDMA++Content+Above+the+Acceptable+Daily+Intake++ADI++Limit Audience: Consumer, Health Professional, Pharmacy November 03, 2020 -- Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended Release... Tue, 03 Nov 2020 10:07:00 GMT https://www.drugs.com/fda/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-usp-750-14408.html?utm_source=ddc&utm_medium=rss&utm_campaign=Nostrum+Laboratories++Inc++Issues+Voluntary+Nationwide+Recall+of+Metformin+HCl+Extended+Release+Tablets++USP+750+mg++Due+to+N+Nitrosodimethylamine++NDMA++Content+Above+the+Acceptable+Daily+Intake++ADI++Limit Audience: Consumer, Health Professional, Pharmacy November 02, 2020 -- Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin... Mon, 02 Nov 2020 09:51:00 GMT https://www.drugs.com/fda/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-14407.html?utm_source=ddc&utm_medium=rss&utm_campaign=Sunstar+Americas+Inc++Issues+Voluntary+Nationwide+Recall+of+Paroex+++Chlorhexidine+Gluconate+Oral+Rinse+USP++0+12++Due+to+Microbial+Contamination Audience: Consumer, Patient, Health Professional, Pharmacy Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific... Wed, 28 Oct 2020 10:46:00 GMT https://www.drugs.com/fda/safety-communication-nonsteroidal-anti-inflammatory-nsaids-avoid-nsaids-pregnancy-20-weeks-later-14406.html?utm_source=ddc&utm_medium=rss&utm_campaign=Drug+Safety+Communication++Nonsteroidal+Anti+Inflammatory+Drugs++NSAIDs++++Avoid+Use+of+NSAIDs+in+Pregnancy+at+20+Weeks+or+Later Audience: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid... Thu, 15 Oct 2020 12:39:00 GMT https://www.drugs.com/fda/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride-14405.html?utm_source=ddc&utm_medium=rss&utm_campaign=Marksans+Pharma+Limited+Issues+Expansion+of+Voluntary+Nationwide+Recall+of+Metformin+Hydrochloride+Extended+Release+Tablets++USP+500mg+++750mg++Due+to+the+Detection+of+N+Nitrosodimethylamine++NDMA+ Audience: Consumer, Health Professional, Pharmacy October 05, 2020 -- Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride... Mon, 05 Oct 2020 09:32:00 GMT https://www.drugs.com/fda/safety-communication-benadryl-diphenhydramine-serious-problems-doses-allergy-medicine-14404.html?utm_source=ddc&utm_medium=rss&utm_campaign=Drug+Safety+Communication++Benadryl++diphenhydramine++++Serious+Problems+with+High+Doses+of+the+Allergy+Medicine Audience: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures,... Thu, 24 Sep 2020 09:16:00 GMT https://www.drugs.com/fda/safety-communication-benzodiazepine-class-boxed-warning-updated-improve-safe-14403.html?utm_source=ddc&utm_medium=rss&utm_campaign=Drug+Safety+Communication++Benzodiazepine+Drug+Class+++Boxed+Warning+Updated+to+Improve+Safe+Use Audience: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This... Wed, 23 Sep 2020 09:03:00 GMT