🍎 Food Class I - Dangerous
A potato stick snack with a milk allergen was found in the O-Organic Sea Salt Popcorn line's recycle chute.
All Recalls
95,025 total recalls in our database
Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02.
Lula Holdings L.L.C.
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
💊 Drugs Class I - Dangerous
Subpotent Drug
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: low out of specification results for dissolution.
💊 Drugs Class I - Dangerous
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Defective container: loose crimp defect, potential loss of container integrity.
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
💊 Drugs Class I - Dangerous
Subpotent Drug
11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Woodside Acquisitions
🏥 Medical Devices Class I - Dangerous
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux
🏥 Medical Devices Class I - Dangerous
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
BF-3C160: EVIS EXERA Bronchovideoscope
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
🏥 Medical Devices Class I - Dangerous
FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).