"FDA Recall: Indomethacin Pain Reliever Pulled from Shelves"

Recall of Indomethacin Extended-Release Capsules

For many Americans, reaching for a pain reliever like ibuprofen or aspirin is a common response to everyday aches and pains. According to data from Harvard Health, about 15% of Americans regularly use nonsteroidal anti-inflammatory drugs (NSAIDs) like Aleve, Motrin, or Celebrex. Additionally, it is estimated that nearly 20% of Americans suffer from arthritis, a condition characterized by joint pain, swelling, and stiffness, as reported by health experts.

When it comes to managing pain, especially in conditions like arthritis, medications like Indomethacin Extended-Release Capsules play a crucial role. These prescription-only capsules are known to help reduce inflammation and alleviate pain associated with arthritis. The medication, classified as an NSAID and also known by the brand name Indocin, is widely prescribed for its efficacy in pain relief.

Reason for the Recall

On May 21, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of 9,107 bottles of Indomethacin Extended-Release Capsules. The recall was initiated due to "cGMP deviations," which are deviations from Current Good Manufacturing Practice regulations set by the FDA to ensure the proper design, monitoring, and control of manufacturing processes and facilities. While the exact nature of the deviations was not specified, the recall has raised concerns about the quality and safety of the medication.

The recall details include:

• Indomethacin Extended-Release Capsules USP, 75 mg
• 100-count bottle
• Prescription-only
• Lot #: 18400A
• Expiration: 7/31/2027
• Manufactured by: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA
• 9,107 bottles affected

The FDA has classified this recall as a Class II event, meaning that the product may cause temporary or medically reversible adverse health effects. Patients who have been prescribed this medication are advised to consult their healthcare providers for guidance.

Manufacturer's Response

The manufacturer of Indomethacin Extended-Release Capsules, KVK-Tech, Inc., based in Newtown, PA, is also the firm responsible for the recall. Despite being known as a leader in the development and manufacture of high-quality, FDA-approved medicines, the company's involvement in the recall raises questions about the production standards and oversight of the medication.

Consumers are urged to be cautious and vigilant when it comes to using prescription medications, especially in light of recalls like this one. Ensuring the quality and safety of the medications they rely on is crucial for managing their health effectively.

Stay Informed

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Remember to consult healthcare professionals if you have concerns about medications or if you are affected by a recall. Your health and safety should always be a top priority.