FDA Drug Class II — Moderate

Zenatane (isotretinoin) Capsules, USP, 10 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 55111-135-81

Hazard

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

Products

Zenatane (isotretinoin) Capsules, USP, 10 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
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18

Units Affected

13,221 cartons