Indomethacin

American Health Packaging has initiated a Class II recall for Indomethacin Extended-Release Capsules, USP, 75 mg, due to cGMP deviations. This voluntary, nationwide recall impacts 21 cartons of Lot #: 1021950, signaling critical manufacturing quality concerns. Procurement and regulatory teams must assess supply chain risks and monitor American Health Packaging's remediation efforts closely.

KVK-Tech, Inc. has initiated a nationwide Class II recall of 9,107 bottles of Indomethacin Extended-Release Capsules USP, 75 mg, due to cGMP deviations identified at its Newtown, PA facility. This voluntary, firm-initiated action, impacting Lot #18400A, signals critical quality system failures. Procurement and regulatory teams must assess supply chain vulnerabilities for Indomethacin and similar NSAIDs, ensuring robust supplier qualification and continuous monitoring to mitigate disruption risks.

Glenmark Pharmaceuticals Inc., USA, initiated a nationwide Class II recall (D-0643-2024) for Indomethacin Extended-Release Capsules, 75 mg, due to failed dissolution specifications. This event, stemming from product manufactured by Glenmark Pharmaceuticals Limited in India, necessitates immediate action from procurement and regulatory teams to assess supply chain vulnerabilities and ensure product quality.