Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations
Fenofibrate Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Affected NDC
31722-0596-90
Compare with the code on your package — it is the most precise check available.
Drug: Fenofibrate Category: Cholesterol Medication
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 |
|---|---|---|---|---|
| Fenofibrate NDC 31722-0596 |
145 mg/1 | Tablet, Film Coated Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero Labs, Ltd. - Unit III
- NDC code
- 31722-596-90
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1211-2018 · 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 Fenofibrate recalls
See all
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Other recalls by Hetero Labs, Ltd. - Unit III
All 2018 recalls
Class II · Moderate risk
Indomethacin Capsules
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
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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