Home / Recalls / Dr. Reddy's Laboratories, Inc. / D-0509-2017

D-0509-2017 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
March 8, 2017
Initiation Date
February 15, 2017
Termination Date
December 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4404 cartons

Product Description

Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81

Reason for Recall

Failed dissolution specifications - low dissolution results at S3 stage.

Distribution Pattern

U.S. Nationwide

Code Information

Lot # KB60197, Exp 2/18

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