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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Defective container; blister packaging inadequately sealed.
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Failed Impurities/Degradation Specifications.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Marketed Without an Approved NDA/ANDA
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Presence of a foreign substance: black hair found embedded in tablet.
Lack of Assurance of Sterility
Lack of Assurance of Sterility