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Class II: temporary or reversible health riskTerminated

Nostrum Laboratories Nitrofurantoin Oral Suspension Recall

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIB…

Nostrum Laboratories, Inc. · Bryan, OH

Risk level
Class II
Reported by FDA
Jun 22, 2016
Recall ID
D-1030-2016
Check your lot numberHow we source this data

Summary

Nostrum Laboratories recalled Nitrofurantoin Oral Suspension starting May 23, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1030-2016 on Jun 22, 2016. Reason: Failed Dissolution Specifications. Status: Terminated.

Why it was recalled

Failed Dissolution Specifications

Product description

Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32

Lot numbers, UPCs & expiration codes

BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017

Where it was sold

Nationwide

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-1030-2016
Classification
Class II
Status
Terminated
Recall initiated
May 23, 2016
FDA report date
Jun 22, 2016
Quantity
2839 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Nostrum Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-1030-2016, exactly as published.

Show all FDA fields
City
Bryan
State
OH
Status
Terminated
Country
United States
Event ID
74194
Address
705 E Mulberry St
Code information
BZP0093A, BZP0094A, BZP0095A, BZP0096A, BZP0097A, Exp 02/2017
Postal code
43506-1432
Report date
Jun 22, 2016
Product type
Drugs
Recall number
D-1030-2016
Classification
Class II
Recalling firm
Nostrum Laboratories, Inc.
Product quantity
2839 bottles
Termination date
Apr 28, 2017
Reason for recall
Failed Dissolution Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
Distribution pattern
Nationwide
Recall initiation date
May 23, 2016
Initial firm notification
Letter
Center classification date
Jun 14, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1030-2016, published Jun 22, 2016. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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