FDA-Drug2017-06-14Class II
Zenatane (isotretinoin) Capsules, USP, 20 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 55111-136-81
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
89,118 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Zenatane (isotretinoin) Capsules, USP, 20 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 55111-136-81
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0884-2017Don't want to check this manually?
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