💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
All Recalls
95,114 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
SUN PHARMACEUTICAL INDUSTRIES
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4
Perrigo Company PLC
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
💊 Drugs Class I - Dangerous
CGMP Deviations: failed stability results, inadequate laboratory investigations,
🏥 Medical Devices Class I - Dangerous
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
🏥 Medical Devices Class I - Dangerous
Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
🏥 Medical Devices Class I - Dangerous
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
DBB-06 Hemodialysis Delivery System
Nikkiso Ltd - Shizuoka Plant
🏥 Medical Devices Class I - Dangerous
Device lacks premarket approval.
🏥 Medical Devices Class I - Dangerous
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
🏥 Medical Devices Class I - Dangerous
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
🏥 Medical Devices Class I - Dangerous
The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).
Alinity m System, Part No. 08N53-002
Abbott Molecular
🏥 Medical Devices Class I - Dangerous
There is a potential for abnormal (non-sigmoidal) amplification curves.