Class II · Moderate risk
Finasteride Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
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
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Affected NDC
31722-0525-90
Compare with the code on your package — it is the most precise check available.
Drug: Finasteride
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 |
|---|---|---|---|---|
| Finasteride NDC 31722-0525 |
5 mg/1 | Tablet, Film Coated Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero Drugs Ltd. - Unit 1
- NDC code
- 31722-525-90
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0453-2017 · 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 Finasteride recalls
See all
Class II · Moderate risk
Finasteride Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Finasteride
cGMP deviations
Class II · Moderate risk
Finasteride Tablets USP
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Finasteride Tablets USP 1 mg
CGMP Deviations: recalling drug products following an FDA inspection.
Other failed specification recalls from 2016
All failed specification recalls
Class II · Moderate risk
Venlafaxine Hydrochloride extended release capsules
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Class II · Moderate risk
Furosemide Tablets USP
Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint.
Class II · Moderate risk
Lisinopril tablets
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Class II · Moderate risk
Temozolomide Capsules
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
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