Product Quest Manufacturing Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65% recall — FDA D-0040-2019
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Complete FDA and NHTSA recall records dated in October 2018.
These records include useful source details for the selected month.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Chrysler(FCA US LLC) is recalling certain 2019 Jeep Cherokee vehicles equipped with 2.4L engines. Improper transmission calibration may result in a stall.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at…
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side…
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have…
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed.…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.