Indomethacin Extended-Release Capsules recalled for cGMP deviations
Amerisource Health Services LLC is recalling Indomethacin Extended-Release Capsules 75 mg due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 21 cartons distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II, and the source text does not report any illnesses or injuries. The recall is based on manufacturing process deviations (cGMP), which represents a potential risk but without documented adverse health consequences.
Plain-English summary
Amerisource Health Services LLC, operating as American Health Packaging in Columbus, Ohio, is voluntarily recalling Indomethacin Extended-Release Capsules, USP, 75 mg due to cGMP deviations. The affected product is sold in cartons containing 30 capsules (3 x 10 blister cards) per carton.
The recall involves Lot #1021950 with expiration date 11/30/2026, with NDC 68084-411-21 (carton) and NDC 68084-411-11 (blister card). A total of 21 cartons were distributed nationwide in the USA.
Patients taking this medication should consult their healthcare provider before discontinuing use. Pharmacists and healthcare providers should quarantine and return the affected lot to the distributor or contact the recalling firm for instructions.
The recalled product
- Product
- INDOMETHACIN (INDOMETHACIN)
- Brand
- INDOMETHACIN
- Manufacturer
- Amerisource Health Services LLC
- Hazard
- cGMP-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1021950
- Exp. 11/30/2026
Distribution
Distributed nationwide across the United States.
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