Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Reported: August 21, 2019 Initiated: July 24, 2019 #D-1722-2019
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
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 2784 bottles
- Distribution
- Natonwide, PR
- Location
- Pine Brook, NJ
Frequently Asked Questions
What product was recalled? ▼
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01. Recalled by Alvogen, Inc. Units affected: 2784 bottles.
Why was this product recalled? ▼
Failed dissolution specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1722-2019.
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