💊 Drugs Class I - Dangerous
cGMP Deviations
All Recalls
95,094 total recalls in our database
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
💊 Drugs Class I - Dangerous
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
cGMP Deviations
Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
💊 Drugs Class I - Dangerous
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
cGMP Deviations
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Terumo Cardiovascular Systems
🏥 Medical Devices Class I - Dangerous
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
🏥 Medical Devices Class I - Dangerous
During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
🏥 Medical Devices Class I - Dangerous
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Maquet Cardiovascular
🏥 Medical Devices Class I - Dangerous
Some batches of product were not sterilized to their minimum sterilization specification.
Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Abbott Diabetes Care
🏥 Medical Devices Class I - Dangerous
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.