🍎 Food Class I - Dangerous
elevated level of lead
All Recalls
95,075 total recalls in our database
💊 Drugs Class I - Dangerous
Failed dissolution specifications: lower than specifications
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
The Harvard Drug Group LLC
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
💊 Drugs Class I - Dangerous
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
💊 Drugs Class I - Dangerous
cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
💊 Drugs Class I - Dangerous
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics
🏥 Medical Devices Class I - Dangerous
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Stryker Spine
🏥 Medical Devices Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
🏥 Medical Devices Class I - Dangerous
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
🏥 Medical Devices Class I - Dangerous
The potential for cracks forming in the breathing circuit hose.
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
🏥 Medical Devices Class I - Dangerous
The head of the phoropter head could come loose and potentially detach due to a default in the assembly.
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
Stryker
🏥 Medical Devices Class I - Dangerous
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Cordis US
🏥 Medical Devices Class I - Dangerous
product mix-up; Vascular stent labeled as one size but contains a different size.
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Ethicon Endo Surgery
🏥 Medical Devices Class I - Dangerous
Identified curing issues with the silicone during the needles manufacturing process.