Drug 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
D-0098-2017
Product summary
- Event
- Event 75162
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,858 prescription packs (115,680 capsules)
- Official record key
drug-enforcement:D-0098-2017
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 79KB60205; Exp. 02/18
Distribution pattern: nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications