Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
All Recalls
95,083 total recalls in our database
Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
Sun Pharmaceutical Industries
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Labeling: Incorrect or Missing Package Insert
Failed Stability Specifications
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Product is being recalled due to low pH value.
NDI P7 Position Sensor, Stereotaxic Instrument
Orthosoft, Inc.
Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
Some eyelets broke from SwiveLock Anchor on insertion.
Potential Patient Demographic Error with Blank Patient ID Field
Some eyelets broke from SwiveLock Anchor on insertion.
Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Abbott Medical Optics Inc. (AMO)
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Product shipped proximate to or past the expiration date listed on the product label.
Healon Pro, Part No. 10270012
Abbott Medical Optics Inc. (AMO)
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Mederi Therapeutics
Product sterility compromised due to breach in sterile barrier package
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
Some eyelets broke from SwiveLock Anchor on insertion.
Missing Dome Pack accessory.
Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.