Reported May 20, 2015 · Terminated
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc.…
Alvogen, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alvogen, Inc · 10 Bloomfield Ave Bldg B Ste 2 · Pine Brook, NJ · 07058-9743
Is this the product you have?
- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
- Lot codes and dates
Lot 457529exp. 08/2016
- Amount recalled
- 13,392 bottles (100 count)
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specification; 6 month time point
This product could cause temporary or reversible health problems — stop using it.
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