Multi event Drug Recall Enforcement Report Class II voluntary initiated by Alvogen, Inc, originally initiated on 07-24-2019 for the product Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01 The product was recalled due to failed dissolution specifications. The product was distributed in Natonwide, Pr 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-1723-2019 | 07-24-2019 | 08-21-2019 | Class II | 4272 bottles | Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01 | Failed dissolution specifications | Terminated |
| D-1722-2019 | 07-24-2019 | 08-21-2019 | Class II | 2784 bottles | Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 | Failed dissolution specifications | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 47781-303 | Nitrofurantoin Monohydrate/ Macrocrystalline | Nitrofurantoin Monohydrate/macrocrystalline | Capsule | Oral | Alvogen Inc. | Human Prescription Drug |
| 52427-285 | Macrobid | Nitrofurantoin Monohydrate/macrocrystalline | Capsule | Oral | Almatica Pharma Llc | Human Prescription Drug |
