MACLEODS PHARMA USA Levofloxacin Tablets, USP 500 mg recall — FDA D-0162-2023
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
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Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
CGMP Deviations:
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary…
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
CGMP Deviations:
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary…
Ford Motor Company (Ford) is recalling certain 2020-2023 Explorer, Lincoln Aviator, and 2020-2022 Lincoln Corsair vehicles equipped with a 360-degree camera. The video output may fail,…
Volvo Car USA, LLC (Volvo Car) is recalling certain 2023 S60, V60, V60CC, V90CC, XC60, XC90, XC40, and C40 vehicles. A diagnostic error in the Brake Control Module 2 (BCM2) may cause a loss…
General Motors, LLC (GM) is recalling certain 2021-2022 Chevrolet Equinox and 2022 GMC Terrain vehicles. The fuel pump module may not consistently provide sufficient fuel to the engine,…
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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