Hydrocodone Bitartrate And Homatropine Methylbromide Tablet
FDA Recall NDC 10702-055
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 Hydrocodone Bitartrate And Homatropine Methylbromide (NDC 10702-055). A significant event, classified as Class III, was initiated on Apr 27, 2021 by Kvk-tech, Inc.. The reported reason for this action was: "Failed Impurities/Degradation 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 III Terminated
Failed Impurities/Degradation Specifications
Apr 27, 2021
May 26, 2021
17,096 bottles
Recall Profile & Regulatory Data
Event ID
87810
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Oct 05, 2022
Product Description
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
Batch or Lot Expiration Information
Lot# Lot: 15684A, Exp 7/2021
Affected Packages Involved in this Recall
10702-055-03Product
10702-055-09Product
10702-055-01Product
10702-055-10Product
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.
