Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Apotex initiated recall of Paroxetine Hydrochloride tablets in US for failed Impurities/degradation Specifications. Apotex Corp.,USA initiated recall of multiple lots (10, 20, 30, 40mg, tablets) of Parotexine Hydrochloride after finding OOS (out of specification) results for Amadori glucose adduct of Paroxetine. Paroxetine tablets are manufactured in Apotex Canada.
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