Class III
Terminated
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- August 29, 2016
- Posted
- October 19, 2016
- Recall Number
- D-0098-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,858 prescription packs (115,680 capsules)
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Failed Dissolution Specifications
Distribution
nationwide
Lot / Code Info
Lot # 79KB60205; Exp. 02/18
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