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
FDA recall notice · announced October 19, 2016 · Dr. Reddy's Laboratories
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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
Notes
Distribution: nationwide
Lot/code information: Lot # 79KB60205; Exp. 02/18
Quantity: 3,858 prescription packs (115,680 capsules)
Status: Terminated
Products in this recall event:
- 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 (D-0098-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.