Multi event Drug Recall Enforcement Report Class II voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 05-22-2017 for the 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 The product was recalled due to failed dissolution specifications: out of specification results observed for low dissolution.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0883-2017 | 05-22-2017 | 06-14-2017 | Class II | 13,221 cartons | 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 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Terminated |
| D-0885-2017 | 05-22-2017 | 06-14-2017 | Class II | 223,650 cartons | Zenatane (isotretinoin) Capsules, USP, 30 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 55111-113-81 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Terminated |
| D-0884-2017 | 05-22-2017 | 06-14-2017 | Class II | 89,118 cartons | Zenatane (isotretinoin) Capsules, USP, 20 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 55111-136-81 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Terminated |
| D-0886-2017 | 05-22-2017 | 06-14-2017 | Class II | 452,290 cartons | Zenatane (isotretinoin) Capsules, USP, 40 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 55111-137-81 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Terminated |
Recalled Products
