All Sterile Products within expiry
Lack of Assurance of Sterility .
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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.
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
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.