Zenatane (isotretinoin) Capsules, USP, 40 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 55111-137-81
Check against the official notice below — it lists the full affected range.
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 40 mg capsules manufactured by Cipla Limited due to failed dissolution specifications, meaning the capsules may not dissolve properly in the body to release the medication as intended. The recall affects 452,290 cartons distributed nationwide in the USA and Puerto Rico across multiple lot numbers with expiration dates ranging from May 2017 through August 2018.
The recall involves numerous lot numbers with various expiration dates. According to the recall record provided, no remedy or instructions for affected consumers are specified.
Written by software from the official notice below. Not reviewed by a lawyer.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason for recall: Failed Dissolution Specifications: out of specification results observed for low dissolution. Distribution: Nationwide in the USA and Puerto Rico Quantity: 452,290 cartons Lot/code info: Lot #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541, KB50542, KB50543, KB50544, KB50545, KB50546, KB50547, KB50548, KB50549, KB50550, KB50551, Exp 07/17; 01KB50643, 01KB50644, KB50640, KB50641, KB50642, KB50645, Exp 08/17; KB50715, KB50716, KB50717, KB50718, KB50719, KB50720, KB50757, KB50758, KB50759, KB50760, KB50761, Exp 09/17; KB50872, KB50874, KB50875, KB50876, KB50916, KB50938, KB50943, Exp 11/17; 01KB60062, 01KB60063, 01KB60064, 01KB60065, 01KB60066, 01KB60101, KB60025, KB60026, KB60027, KB60028, KB60029, KB60030, KB60031, KB60032, KB60059, KB60060, KB60061, Exp 12/17; 01KB60100, 01KB60161, Exp 01/18; 01KB60256, 01KB60257, 01KB60258, 01KB60259, 01KB60260, Exp 03/18; 01KB60292, 01KB60293, 01KB60294, 01KB60314, 01KB60321, 01KB60333, 01KB60334, 79KB60295, 79KB60296, 79KB60332, 79KB60335, 79KB60346, Exp 04/18; 01KB60393, 01KB60394, 79KB60390, 79KB60391, 79KB60392, Exp 05/18; 01KB60505, 01KB60506, 01KB60538, 79KB60502, 79KB60503, 79KB60504, 79KB60535, 79KB60536, 79KB60537, 79KB60539, 79KB60542, Exp 07/18; 01KB60589, 79KB60566, 79KB60567, 79KB60568, 79KB60569, 79KB60587, 79KB60588, Exp 08/18
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.