Drug recall D-0507-2017
Product
Zenatane (isotretinoin) capsules, 20 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 55111-136-81
Reason for recall
Failed dissolution specifications - low dissolution results at S3 stage.
Lots and codes
Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 12132 cartons
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 15, 2017
- Terminated
- December 19, 2018
Related products
- Zenatane – drug information
- NDC 55111-136 Zenatane · Isotretinoin 20 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-113 Zenatane · Isotretinoin 30 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-137 Zenatane · Isotretinoin 40 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-135 Zenatane · Isotretinoin 10 mg/1 · Dr. Reddy's Laboratories Limited