Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:…
- Recall date
- February 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0509-2017
- FDA classification
- Class III
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- U.S. Nationwide
Why it was recalled
Failed dissolution specifications - low dissolution results at S3 stage.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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