D-0508-2017 Class III Terminated
FDA drug recall D-0508-2017 was initiated by Dr. Reddy's Laboratories, Inc. on February 15, 2017 and is designated Class III. Reason for recall: Failed dissolution specifications - low dissolution results at S3 stage. The recall status is terminated (terminated December 19, 2018). Affected quantity: 4014 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- February 15, 2017
- Termination Date
- December 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4014 cartons
Product Description
Zenatane (isotretinoin) capsules, 30 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 5511-113-81
Reason for Recall
Failed dissolution specifications - low dissolution results at S3 stage.
Distribution Pattern
U.S. Nationwide
Code Information
Lot # KB60036, Exp 12/17