💊 Drugs Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
All Recalls
95,075 total recalls in our database
Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.
West-Ward Columbus
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications:
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Bryant Ranch Prepack
💊 Drugs Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
💊 Drugs Class I - Dangerous
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Bryant Ranch Prepack
💊 Drugs Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Hetero Labs, Ltd. - Unit III
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
💊 Drugs Class I - Dangerous
Carcinogen impurity detected in API used to manufacture drug product.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
💊 Drugs Class I - Dangerous
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
💊 Drugs Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications: Tablet breakage
💊 Drugs Class I - Dangerous
Failed Stability Specifications: lot out of specification for elevated water vapor.
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications: Tablet breakage
💊 Drugs Class I - Dangerous
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Stryker Neurovascular
🏥 Medical Devices Class I - Dangerous
There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure.
🏥 Medical Devices Class I - Dangerous
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
🏥 Medical Devices Class I - Dangerous
Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack.
CT Goldseal Optima CT 600
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
🏥 Medical Devices Class I - Dangerous
Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
🏥 Medical Devices Class I - Dangerous
A review of complaints identified a trend for drills breaking.