Dr. Reddy's Laboratories, Inc.: 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 In

Is my product affected?

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

• Brand ZENATANE

Check against the official notice below — it lists the full affected range.

What happened

Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 20 mg capsules nationwide in the USA and Puerto Rico due to failed dissolution specifications, meaning the capsules are dissolving slower than required. The recall affects approximately 89,118 cartons with multiple lot numbers expiring between May 2017 and June 2018.

The source document does not specify what consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Dissolution Specifications: out of specification results observed for low dissolution.

Details from the source

Reason for recall: Failed Dissolution Specifications: out of specification results observed for low dissolution. Distribution: Nationwide in the USA and Puerto Rico Quantity: 89,118 cartons Lot/code info: 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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