D-0453-2017 Class III Terminated
FDA drug recall D-0453-2017 was initiated by Hetero Drugs Ltd. - Unit 1 on December 29, 2016 and is designated Class III. Reason for recall: Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product. The recall status is terminated (terminated July 11, 2017). Affected quantity: 20,412 units.
Recall Details
- Product Type
- Drugs
- Report Date
- February 8, 2017
- Initiation Date
- December 29, 2016
- Termination Date
- July 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,412 units
Product Description
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
Reason for Recall
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Distribution Pattern
NJ only.
Code Information
Lot #: FIN16002, Exp. 03/2018