💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
All Recalls
95,089 total recalls in our database
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Making It a Lifestyle
💊 Drugs Class I - Dangerous
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Town and Country Compounding and Consultation Services
💊 Drugs Class I - Dangerous
Non-Sterility; microbial contamination identified as Bacillus circulans
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
VIRTUS PHARMACEUTICALS OPCO II L
💊 Drugs Class I - Dangerous
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Guardian Pharmacy Services
💊 Drugs Class I - Dangerous
Non-Sterility: failed sterility test result.
🏥 Medical Devices Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
🏥 Medical Devices Class I - Dangerous
Product sterility is compromised due to breach of the sterile barrier
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Ultroid Technologies
🏥 Medical Devices Class I - Dangerous
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
🏥 Medical Devices Class I - Dangerous
BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
🏥 Medical Devices Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
🏥 Medical Devices Class I - Dangerous
Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.
🏥 Medical Devices Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
🏥 Medical Devices Class I - Dangerous
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
🏥 Medical Devices Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
🏥 Medical Devices Class I - Dangerous
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
🏥 Medical Devices Class I - Dangerous
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.