Drug product
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
D-0509-2017
Product summary
- Event
- Event 76539
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4404 cartons
- Official record key
drug-enforcement:D-0509-2017
Official wording
Reason: Failed dissolution specifications - low dissolution results at S3 stage.
Code information: Lot # KB60197, Exp 2/18
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications