D-1722-2019 Class II Terminated
FDA drug recall D-1722-2019 was initiated by Alvogen, Inc on July 24, 2019 and is designated Class II. Reason for recall: Failed dissolution specifications The recall status is terminated (terminated August 4, 2021). Affected quantity: 2784 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- July 24, 2019
- Termination Date
- August 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2784 bottles
Product Description
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Reason for Recall
Failed dissolution specifications
Distribution Pattern
Natonwide, PR
Code Information
Lot # 471976, Exp 03/2020