Recalls / Class III
Class IIID-0509-2017
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
- Brand name
- Zenatane
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 55111-113, 55111-135, 55111-136, 55111-137
- FDA application
- ANDA202099
- Affected lot / code info
- Lot # KB60197, Exp 2/18
Why it was recalled
Failed dissolution specifications - low dissolution results at S3 stage.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4404 cartons
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-02-15
- FDA classified
- 2017-03-02
- Posted by FDA
- 2017-03-08
- Terminated
- 2018-12-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.