FDAFDA · Food and drugs·Recall number D-0884-2017
Zenatane (isotretinoin) Capsules, USP, 20 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 55111-136-81
Published June 14, 2017 · Recall initiated: May 22, 2017
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: out of specification results observed for low dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ZENATANE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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