Recalls / Class III
Class IIID-0453-2017
Product
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
- Brand name
- Finasteride
- Generic name
- Finasteride
- Active ingredient
- Finasteride
- Route
- Oral
- NDC
- 31722-525
- FDA application
- ANDA090061
- Affected lot / code info
- Lot #: FIN16002, Exp. 03/2018
Why it was recalled
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Recalling firm
- Firm
- Hetero Drugs Ltd. - Unit 1
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot Nos. 213, 214, 255, Bonthapally Village, Jinnaram Mandal, Medak District, N/A N/A, India
Distribution
- Quantity
- 20,412 units
- Distribution pattern
- NJ only.
Timeline
- Recall initiated
- 2016-12-29
- FDA classified
- 2017-01-31
- Posted by FDA
- 2017-02-08
- Terminated
- 2017-07-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0453-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.