Macrobid Capsule
FDA Recall NDC 52427-285
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Macrobid (NDC 52427-285). A significant event, classified as Class II, was initiated on Jul 24, 2019 by Almatica Pharma Llc. The reported reason for this action was: "Failed dissolution specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed dissolution specifications
Jul 24, 2019
Aug 21, 2019
4272 bottles
Recall Profile & Regulatory Data
Event ID
83434
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Alvogen, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Natonwide, PR
Termination Date
Aug 04, 2021
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
Batch or Lot Expiration Information
Lot# 472990, Exp 03/2020
Affected Packages Involved in this Recall
52427-285-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
