FDAClass IIRecall started July 24, 2019

Macrobid Urinary Tract Anitbacterial 100 mg Recall: Failed Dissolution

Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by…

What is the FDA recall status?

The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.

How FDA enforcement data reports status

Why was Macrobid Urinary Tract Anitbacterial 100 mg recalled?

Failed dissolution specifications

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01

Which lot codes, UPCs or models are affected?

Lot # 472990, Exp 03/2020

Agency record number
D-1723-2019
Product
Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by…
Recalling firm
Alvogen, Inc
Quantity
4272 bottles
Distribution
Natonwide, PR
Recall started
July 24, 2019
Report date
August 21, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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