Product may contain foreign object that appears to be of rodent origin.
All Recalls
95,114 total recalls in our database
Potential under-processing.
CGMP Deviations: Out of specification for dissolution
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Zydus Pharmaceuticals (USA)
Presence of particulate matter: glass
CGMP Deviations
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
Homeocare Laboratories
Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Failed Dissolution Specifications
Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Failed Impurities/Degradation Specifications
CGMP Deviations
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Homeocare Laboratories
Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Failed Impurities/Degradation Specifications
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: results below specifications
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Alcon Research
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.