Recall: D-0453-2017

Class III - Minor Violations

Class IIIClassification

2016-12-29Initiated

TerminatedStatus

Hetero Drugs Ltd. - Unit 1Firm

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

Reason

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Distribution

NJ only.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.