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Class II: temporary or reversible health riskTerminated

Alvogen Nitrofurantoin Monohydrate/Macrocrystals Recall

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --…

Alvogen, Inc · Pine Brook, NJ

Risk level
Class II
Reported by FDA
May 20, 2015
Recall ID
D-1082-2015
Check your lot numberHow we source this data

Summary

Alvogen recalled Nitrofurantoin Monohydrate/Macrocrystals starting Apr 21, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1082-2015 on May 20, 2015. Reason: Failed Dissolution Specification; 6 month time point. Status: Terminated.

Why it was recalled

Failed Dissolution Specification; 6 month time point

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

Lot numbers, UPCs & expiration codes

Lot 457529, exp. 08/2016

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1082-2015
Classification
Class II
Status
Terminated
Recall initiated
Apr 21, 2015
FDA report date
May 20, 2015
Quantity
13,392 bottles (100 count)
Recall type
Voluntary: Firm initiated
Recalling firm
Alvogen, Inc

Original FDA data

Every field from FDA enforcement report D-1082-2015, exactly as published.

Show all FDA fields
City
Pine Brook
State
NJ
Status
Terminated
Country
United States
Event ID
71003
Address
10 Bloomfield Ave Bldg B Ste 2
Code information
Lot 457529, exp. 08/2016
Postal code
07058-9743
Report date
May 20, 2015
Product type
Drugs
Recall number
D-1082-2015
Classification
Class II
Recalling firm
Alvogen, Inc
Product quantity
13,392 bottles (100 count)
Termination date
Dec 4, 2015
Reason for recall
Failed Dissolution Specification; 6 month time point
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Apr 21, 2015
Initial firm notification
Letter
Center classification date
May 14, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1082-2015, published May 20, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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