Hydrocodone Bitartrate And Homatropine Methylbromide Liquid
FDA Recall NDC 10702-150
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 10702-150). A significant event, classified as Class II, was initiated on Nov 01, 2019 by Kvk-tech, Inc.. The reported reason for this action was: "Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection"
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
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Nov 01, 2019
Nov 20, 2019
1534 bottles
Recall Profile & Regulatory Data
Event ID
84184
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
KVK-Tech, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 16, 2020
Product Description
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16
Batch or Lot Expiration Information
Lot# : 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN
Affected Packages Involved in this Recall
10702-150-16Product
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.
