Dr. Reddy's Laboratories, Inc. recalls Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By…
- Recall date
- May 22, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0885-2017
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Zenatane (isotretinoin) Capsules, USP, 30 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 55111-113-81
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