💊 Drugs Class I - Dangerous
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
All Recalls
95,102 total recalls in our database
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
Zydus Pharmaceuticals (USA)
💊 Drugs Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
💊 Drugs Class I - Dangerous
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
💊 Drugs Class I - Dangerous
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
Zydus Pharmaceuticals (USA)
💊 Drugs Class I - Dangerous
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
💊 Drugs Class I - Dangerous
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61
The Harvard Drug Group LLC
💊 Drugs Class I - Dangerous
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Boston Scientific
🏥 Medical Devices Class I - Dangerous
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC,785-ER-ILC.
WASATCH PHOTONICS
🏥 Medical Devices Class I - Dangerous
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
🏥 Medical Devices Class I - Dangerous
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Limited system movements after startup .
IntelliSpace Cardiovascular, Software 8.0.0.4.
Philips Medical Systems Nederland B.V.
🏥 Medical Devices Class I - Dangerous
Software issue that results in the display of outdated information.
🏥 Medical Devices Class I - Dangerous
Measles IgM Test Kit lacks premarket approval or clearance.
🏥 Medical Devices Class I - Dangerous
Dipstick strep A test has potential for false positive results.
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Potential for undetected, deformed a-traumatic tips.
🏥 Medical Devices Class I - Dangerous
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
🏥 Medical Devices Class I - Dangerous
Potential for open header bag seals, compromising sterility.
Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
SEASPINE ORTHOPEDICS
🏥 Medical Devices Class I - Dangerous
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.