Ninjacof recall — FDA D-1140-2017
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,690 detailed records are currently available in this category.
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Failed moisture limits: Out of specification for moisture content.
Defective container: Oral solution leaking from container.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
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