Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Indomethacin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01.
Affected NDC
31722-0543-01
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 31722-0543 |
50 mg/1 | Capsule Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- NDC code
- 31722-543-01
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1019-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Hetero Labs, Ltd. - Unit III
All 2018 recalls
Class III · Low risk
Fenofibrate Tablets
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class III · Low risk
Simvastatin Tablets
Presence of foreign substance: metallic razor blade was found in one bottle.
Class II · Moderate risk
Levetiracetam Oral Solution
Presence of foreign substance (screw)
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