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Medicine Recalls

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System. 12/2/2019

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. 11/26/2019

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below. Ranitidine Tablets, USP, 150 mg and 300 mg 11/22/2019

The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. 11/19/2019

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. 11/19/2019

The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death. 11/15/2019 8:00:00 AM

Nature?s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. 11/13/2019

The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin. 11/8/2019 10:00:00 AM

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f 11/8/2019

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level. 11/8/2019

The detector on the Forte Gamma Camera System has the potential to become detached without warning which could result in a serious injury or death. 11/7/2019 8:00:00 AM

Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient. 11/7/2019

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in 11/6/2019

Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms. 11/6/2019

Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann 11/5/2019

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication. 11/5/2019

The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. 11/4/2019 4:25:00 AM

Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs. 11/1/2019

Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death. 10/30/2019

The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX. 10/28/2019

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance 10/26/2019

Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup 10/25/2019

Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. 10/25/2019

As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150?, Zantac 150? Cool Mint, and Zantac 75?. 10/23/2019

The list below contains recalls that were issued in 2019. 10/8/2019 10:00:00 AM