Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Indomethacin Capsules USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01.
Affected NDC
68462-0302-01
Compare with the code on your package — it is the most precise check available.
Drug: Indomethacin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Indomethacin NDC 68462-0302 |
50 mg/1 | Capsule Oral |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-302-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0606-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Indomethacin recalls
See all
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Class II · Moderate risk
Indomethacin 25mg Capsules
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2018 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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