NingBo Huize Commodity Co AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED recall — FDA D-1547-2019
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
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CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Subpotent Drug
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
cGMP Deviations: Products may have microbial contamination.
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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