FDA Drug Class III — Least Serious

Zenatane (isotretinoin) capsules, 20 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 55111-136-81

Hazard

Failed dissolution specifications - low dissolution results at S3 stage.

Products

Zenatane (isotretinoin) capsules, 20 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
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18

Units Affected

12132 cartons