Recalls / Class III
Class IIID-0098-2017
Product
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
- 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 # 79KB60205; Exp. 02/18
Why it was recalled
Failed Dissolution Specifications
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
- 3,858 prescription packs (115,680 capsules)
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2016-08-29
- FDA classified
- 2016-10-13
- Posted by FDA
- 2016-10-19
- Terminated
- 2019-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0098-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.