D-0507-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- February 15, 2017
- Termination Date
- December 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12132 cartons
Product Description
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Reason for Recall
Failed dissolution specifications - low dissolution results at S3 stage.
Distribution Pattern
U.S. Nationwide
Code Information
Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18