Drug 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
D-0883-2017
Product summary
- Event
- Event 77353
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,221 cartons
- Official record key
drug-enforcement:D-0883-2017
Official wording
Reason: Failed Dissolution Specifications: out of specification results observed for low dissolution.
Code information: Lot #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification