FDAFDA · Food and drugs·Recall number D-0098-2017
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
Published October 19, 2016 · Recall initiated: August 29, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZENATANE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- nationwide
- Lot
- Lot # 79KB60205; Exp. 02/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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