The U.S. Food and Drug Administration has updated a health risk for more than 9,000 bottles of recalled pain reliever medications that were distributed nationwide.
Manufactured by KVK-Tech, Inc., 100-count bottles of Indomethacin Extended-Release Capsules USP, 75 mg are in included in this recall due to quality issues.
The product is under recall for deviations from Current Good Manufacturing Practice, which is the main regulatory standard for ensuring pharmaceutical quality. This practice ensures that each batch of medicines that consumers take meet quality standards so that they will be safe and effective.
It involves lot codes 18400A with an expiration date of July 31, 2027.
The medication is commonly used to treat mild to moderate acute pain and relieve symptoms or arthritis.
A recall of these products was initiated on May 9.
The FDA classified the risk level of this recall to Class II last week. A Class II recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recall of this product remains ongoing, according to the agency.