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Latest Alerts

Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall
Aurobindo Pharma USA is voluntarily recalling a single lot of gabapentin capsules 300 mg in 100-count bottles. The affected lot number is GESB14011-A with an expiration date of 12/2015 and has NDC 16714-662-01 on the label. Bottles in this lot have been found to contain some empty capsules. The recalled product was manufactured by Aurobindo Pharma Limited and was distributed with a Northstar Rx label to retail outlets nationwide. Gabapentin is commonly used in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). Gabapentin is available from many generic manufacturers and under the brand name Neurontin. Gabapentin is also available in other capsule strengths. This recall alert only affects gabapentin 300 mg capsules from lot GESB14011-A made by Aurobindo and distributed by Northstar Rx. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm424470.htm To view a photograph of the original packaging and labeling, please visit: http://www.fda.gov/Safety/Recalls/ucm424475.htm
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FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient)
The US Food and Drug Administration (FDA) is reviewing data from a clinical research study called the Dual Antiplatelet Therapy (DAPT) study comparing the benefits and risks of 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents. These stents are small, medicine-coated tubes inserted into narrowed arteries in the heart to keep them open and maintain blood flow to the heart. Clopidogrel and prasugrel are important medicines used to prevent heart attacks, strokes, and other clot-related diseases. The DAPT study, published in the New England Journal of Medicine on November 16, 2014, reported that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared with 12 months of treatment. The higher rate of death can be explained by an increase in deaths from non–heart-related causes, primarily cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not in those given prasugrel. Increases in non–heart-related death have not been reported in previous large studies examining clopidogrel for other heart-related diseases. At this time, the FDA is evaluating the study results and has not reached any conclusions based on the findings from this clinical study. The FDA will communicate their final conclusions and recommendations when their evaluation is complete. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm423079.htm
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Date Published Title Drug Source
2014-11-25 Empty Gabapentin 300 mg Capsules From Aurobindo Pharma Prompt Recall Gabapentin FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-17 FDA Reviews Recently Published Study Data for Long-term Antiplatelet Therapy Clopidogrel (Plavix) or Prasugrel (Effient) Prasugrel FDA
2014-11-14 FDA Raises Concern About Generic Extended-Release Methylphenidate Hydrochloride Tablets (generic Concerta) made by Mallinckrodt and Kudco Methylphenidate FDA
2014-07-03 Oral Lidocaine for Teething Pain May Cause Harm Lidocaine FDA
2014-06-30 FDA Warns That Over-the-Counter Topical Acne Medicines May Cause Serious Allergic Reactions Benzoyl Peroxide FDA
2014-06-26 FDA Warns: Docetaxel May Cause Alcohol Intoxication Docetaxel FDA
2014-06-24 FDA Adds Blood Clot Warning to Testosterone Products Methyltestosterone FDA
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Manufacturer
2014-06-13 Diabetic Supply of Suncoast, Inc. Recalls Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips Tolazamide Manufacturer
2014-05-21 FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ Hydrocortisone with Pramoxine FDA
2014-05-19 FDA Requires Lower Starting Dose of Lunesta (eszopiclone) to Reduce Risk of Next-Day Impairment Eszopiclone FDA
2014-05-14 FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran) Dabigatran FDA
2014-05-08 Alere Recalls Alere INRatio®2 PT/INR Professional Test Strips Warfarin FDA
2014-05-07 FDA Addresses the Question: “Can an Aspirin a Day Help Prevent a Heart Attack?” Aspirin FDA
2014-05-01 FDA Issues Reminder Warning for Combination Medicines Containing Acetaminophen Acetaminophen with Oxycodone FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips FDA
2014-05-01 FDA Warns: Stop Using GenStrip™ Blood Glucose Test Strips Tolazamide FDA
2014-04-01 FDA Clarifies Warning About Use of Revatio for Pulmonary Arterial Hypertension in Children Sildenafil FDA
2014-03-31 GlaxoSmithKline Reports Product Tampering With alli® Orlistat Manufacturer
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