D-0883-2017 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
- 13,221 cartons
Product Description
Zenatane (isotretinoin) Capsules, USP, 10 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 55111-135-81
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 #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18