FDA Drug Class III — Least Serious

Zenatane (isotretinoin) capsules, 40 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 55111-137-81

Hazard

Failed dissolution specifications - low dissolution results at S3 stage.

Products

Zenatane (isotretinoin) capsules, 40 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 # 01KB60250, Exp 3/18

Units Affected

4032 cartons