Indomethacin Extended-Release Capsules USP
cGMP deviations
676 recalls · Class II, newest first
cGMP deviations
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Presence of Particulate Matter: Glass particles were found in pellet vials.
CGMP Deviations
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations