LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
All Recalls
95,102 total recalls in our database
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
The Harvard Drug Group LLC
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product Description: Influenza A And Influenza B Multiplex Nucleic Acid Assay; Real Time Nucleic Acid Component: No
Abbott Diagnostics Scarborough
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Lack of sterility assurance for closed suction catheter systems
t:slim X2 Insulin Pump with Interoperable Technology
Tandem Diabetes Care
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Welch Allyn Connex Vital Signs Monitor (CVSM):
Baxter Healthcare
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Refer to RES
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No
Abbott Diagnostics Scarborough
the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Welch Allyn CONNEX Accessory Power Management Stand:
Baxter Healthcare
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
MEDLINE INDUSTRIES, LP - Northfield
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Lack of sterility assurance for closed suction catheter systems