Drug recall D-0098-2017
Product
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
Reason for recall
Failed Dissolution Specifications
Lots and codes
Lot # 79KB60205; Exp. 02/18
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 3,858 prescription packs (115,680 capsules)
- Distribution
- nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 29, 2016
- Terminated
- November 8, 2019
Related products
- Zenatane – drug information
- NDC 55111-136 Zenatane · Isotretinoin 20 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-113 Zenatane · Isotretinoin 30 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-137 Zenatane · Isotretinoin 40 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-135 Zenatane · Isotretinoin 10 mg/1 · Dr. Reddy's Laboratories Limited