Multi event Drug Recall Enforcement Report Class III voluntary initiated by Micro Labs Usa, Inc S, originally initiated on 12-04-2014 for the product Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90. The product was recalled due to failed impurities/degradation specifications: product failed a known impurity specification.. 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-0408-2015 | 12-04-2014 | 03-18-2015 | Class III | 13488 bottles | Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90. | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Terminated |
| D-0407-2015 | 12-04-2014 | 03-18-2015 | Class III | 240 (1000-count bottle), 26,904 (90-count bottle) | Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540 | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Terminated |
| D-0409-2015 | 12-04-2014 | 03-18-2015 | Class III | 13464 bottles | Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90. | Failed Impurities/Degradation Specifications: Product failed a known impurity specification. | Terminated |
Recalled Products
