Amyloid Complete
FoodScience
🍎 Food Class I - Dangerous
Contains undeclared crustacean shellfish (shrimp & crab)
All Recalls
95,114 total recalls in our database
🍎 Food Class I - Dangerous
Potential contamination with Listeria Monocytogenes
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Hikma Injectables USA
💊 Drugs Class I - Dangerous
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
SUN PHARMACEUTICAL INDUSTRIES
💊 Drugs Class I - Dangerous
Failed Release Testing: Out of specification for particulate matter test.
💊 Drugs Class I - Dangerous
Subpotent product in addition to having out-of-specification results for impurities.
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility.
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Philips North America
🏥 Medical Devices Class I - Dangerous
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
🏥 Medical Devices Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).