Olympia Compounding Pharmacy dba Olympia T-50, Papaverine 8 mg/mL recall — FDA D-0820-2022
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
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CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Labeling: Missing label on the vial
Subpotent Drug: Out of specification for assay.
Tesla, Inc. (Tesla) is recalling certain 2021-2022 Model S, Model X, and 2022 Model 3 and Model Y vehicles operating certain firmware releases. The infotainment central processing unit…
Chrysler (FCA US, LLC) is recalling certain 2021 Dodge Durango, Jeep Grand Cherokee WK, 2022 Jeep Grand Cherokee, and 2021-2022 Jeep Grand Cherokee L vehicles equipped with 3.6L engines.…
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual…
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Out of specification results observed in dissolution during long term stability testing.
Presence of Particulate Matter: Product was found to contain silica and iron oxide
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
BMW of North America, LLC (BMW) is recalling certain 2022 4 Series Gran Coupe (430i, 430i xDrive, M440i xDrive); 2019-2022 X5 sDrive40i, X5 xDrive40i, X5 xDrive50i, X5 M50i, X5M; 2021-2022…
Tesla, Inc. (Tesla) is recalling one 2022 Model X vehicle. A body structure reinforcement bracket was not installed at the second-row seat. As such, this vehicle fails to comply with the…
Tesla, Inc. (Tesla) is recalling certain 2018-2022 Model 3 Performance vehicles. The unit of speed (mph or km/h) may fail to display on the speedometer while in Track Mode. As such, these…
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