Drug recall
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals…
FDA recall event 83434 · Class II · Alvogen, Inc
Key facts
| Event ID | 83434 |
|---|---|
| Recall numbers | D-1722-2019, D-1723-2019 |
| Recalling firm | Alvogen, Inc |
| Product type | Drugs |
| Products | 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…, Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution specifications |
| Initiation date | Jul 24, 2019 |
| Report date | Aug 21, 2019 |
| Termination date | Aug 4, 2021 |
| City | Pine Brook |
| State | NJ |
| Country | United States |
| FEI number | 3008454186 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: