Nitrofurantoin Monohydrate/macrocrystals Capsules recall: Failed Dissolution
NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
Why was Nitrofurantoin Monohydrate/macrocrystals Capsules recalled?
Failed Dissolution Specification; 6 month time point
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 457529, exp. 08/2016
- Product
- NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01
- Recalling firm
- Alvogen, Inc
- Quantity
- 13,392 bottles (100 count)
- Distribution
- Nationwide and Puerto Rico
- Recall date
- May 20, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)