Recalls / Class II
Class IID-0883-2017
Product
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, 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 #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18
Why it was recalled
Failed Dissolution Specifications: out of specification results observed for low dissolution.
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
- 13,221 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-05-22
- FDA classified
- 2017-06-02
- Posted by FDA
- 2017-06-14
- Terminated
- 2018-11-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0883-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.