Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials recall — FDA D-0917-2023
Presence of Particulate Matter: Particulate matter identified as fiber.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Presence of Particulate Matter: Particulate matter identified as fiber.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be…
Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Presence of Particulate Matter: Particulate matter identified as fiber.
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.
Tesla, Inc. (Tesla) is recalling certain 2021-2023 Model S and Model X vehicles. The front-row seat belts may not be connected properly to the pretensioner anchors, which can cause the seat…
Tesla, Inc. (Tesla) is recalling certain 2023 Model S, Model X, and Model Y vehicles. The forward-facing camera may be misaligned, causing some of the active safety features such as…
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain…
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain…
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so…
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