Hydrocodone Bitartrate And Acetaminophen Tablet
FDA Recall NDC 43386-358
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 Acetaminophen (NDC 43386-358). A significant event, classified as Class III, was initiated on May 24, 2018 by Lupin Pharmaceuticals,inc.. The reported reason for this action was: "Labeling: Missing Label"
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
Labeling: Missing Label
May 24, 2018
Jun 06, 2018
1,672 (1000-count) bottles
Recall Profile & Regulatory Data
Event ID
80187
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LUPIN SOMERSET
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH
Termination Date
Jan 26, 2021
Product Description
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Batch or Lot Expiration Information
Lot# S800257; Exp. 01/20
Affected Packages Involved in this Recall
43386-358-05Product
43386-358-01Product
43386-358-10Product
43386-358-03Product
43386-357-01Product
43386-357-05Product
43386-357-10Product
43386-357-03Product
43386-356-01Product
43386-356-05Product
43386-356-10Product
43386-356-03Product
3433863561Product
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.
