FDA-Drug2017-03-08Class III
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
Dr. Reddy's Laboratories, Inc.
Hazard
Failed dissolution specifications - low dissolution results at S3 stage.
Sold states
U.S. Nationwide
Affected count
4404 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0509-2017Don't want to check this manually?
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