Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
All Recalls
95,075 total recalls in our database
Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1.
Magno Humphries Laboratories
💊 Drugs Class I - Dangerous
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
💊 Drugs Class I - Dangerous
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
💊 Drugs Class I - Dangerous
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
💊 Drugs Class I - Dangerous
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
💊 Drugs Class I - Dangerous
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Hetero Labs Limited Unit V
💊 Drugs Class I - Dangerous
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
🏥 Medical Devices Class I - Dangerous
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Contamination with Methylbacterium thiocyanatum
🏥 Medical Devices Class I - Dangerous
The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
Video Cystoscope models ECY-1570 and ECY-1570K
Pentax of America
🏥 Medical Devices Class I - Dangerous
The video cytoscopes lack 510(k) premarket notification clearance.
Central venous catheters may not fit over guide wire potentially causing procedure delay.
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
LITTLE RAPIDS
🏥 Medical Devices Class I - Dangerous
The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
🏥 Medical Devices Class I - Dangerous
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
B. Braun Medical
🏥 Medical Devices Class I - Dangerous
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
🏥 Medical Devices Class I - Dangerous
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
🏥 Medical Devices Class I - Dangerous
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.