Paroxetine tablets USP
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
893 recalls · Class II, newest first
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Lack of Assurance of Sterility .
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
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.
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.
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.