Hydrocodone Bitartrate And Homatropine Methylbromide Tablet
FDA Recall NDC 43386-118
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 43386-118). A significant event, classified as Class III, was initiated on Mar 05, 2018 by Lupin Pharmaceuticals,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
Mar 05, 2018
Mar 21, 2018
134,364 bottles (4,030,920 tablets)
Recall Profile & Regulatory Data
Event ID
79298
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novel Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 08, 2020
Product Description
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
Batch or Lot Expiration Information
Lot# M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019)
Affected Packages Involved in this Recall
43386-118-03Product
43386-118-01Product
43386-118-05Product
3433861180Product
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.
