D-0884-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- November 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,118 cartons
Product Description
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, 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: out of specification results observed for low dissolution.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18