NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Reported: May 20, 2015 Initiated: April 21, 2015 #D-1082-2015
Product Description
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Reason for Recall
Failed Dissolution Specification; 6 month time point
Details
- Recalling Firm
- Alvogen, Inc
- Units Affected
- 13,392 bottles (100 count)
- Distribution
- Nationwide and Puerto Rico
- Location
- Pine Brook, NJ
Frequently Asked Questions
What product was recalled? ▼
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01. Recalled by Alvogen, Inc. Units affected: 13,392 bottles (100 count).
Why was this product recalled? ▼
Failed Dissolution Specification; 6 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 20, 2015. Severity: Moderate. Recall number: D-1082-2015.
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