Multi event Drug Recall Enforcement Report Class II voluntary initiated by Heritage Pharmaceuticals, Inc., originally initiated on 02-25-2015 for the product RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31 The product was recalled due to lack of assurance of sterility: firm is recalling two injectable products due to concerns with quality control processes.. 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-0416-2015 | 02-25-2015 | 03-25-2015 | Class II | 24,344 vials | RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31 | Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. | Terminated |
| D-0415-2015 | 02-25-2015 | 03-25-2015 | Class II | | Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 | Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. | Terminated |
Recalled Products
