Drug recall D-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
Reason for recall
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Lots and codes
Lot #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 13,221 cartons
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 22, 2017
- Terminated
- November 19, 2018
Related products
- Zenatane – drug information
- NDC 55111-136 Zenatane · Isotretinoin 20 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-113 Zenatane · Isotretinoin 30 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-137 Zenatane · Isotretinoin 40 mg/1 · Dr. Reddy's Laboratories Limited
- NDC 55111-135 Zenatane · Isotretinoin 10 mg/1 · Dr. Reddy's Laboratories Limited