FDA-Drug2019-08-21Class II

Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01

Alvogen, Inc
Hazard

Failed dissolution specifications

Sold states
Natonwide, PR
Affected count
2784 bottles
Manufactured in
10 Bloomfield Ave Bldg B Ste 2, N/A, Pine Brook, NJ, United States
Products
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1722-2019

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