Allergy Relief Tablet, Orally Disintegrating
FDA Recall NDC 51660-527
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 Allergy Relief (NDC 51660-527). A significant event, classified as Class III, was initiated on Jul 28, 2015 by Ohm Laboratories Inc.. The reported reason for this action was: "Superpotent Drug: Out Of Specification (OOS) result for Assay."
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 III Terminated
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Jul 28, 2015
Oct 21, 2015
311 boxes
Recall Profile & Regulatory Data
Event ID
71973
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ohm Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Oct 28, 2016
Product Description
Ohm Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets, Distributed by Ohm Laboratories, Inc. 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 51660-527-31, UPC 3 5166052731 5
Batch or Lot Expiration Information
Batch# Batch Numbers: 2544486, Exp 7/31/2016; 2617891, Exp 5/31/2016; 2644272, Exp 9/30/2016
Affected Packages Involved in this Recall
51660-527-31Product
5166052731Product
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.
