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Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
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.
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
Discoloration; discolored solution from cracked vials
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.