March 2018 FDA Recall Hydrocodone Bitartrate And Homatropine Methylbromide by Novel Laboratories, Inc.
D-0599-2018 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Novel Laboratories, Inc. on March 5, 2018 for the product Hydrocodone Bitartrate And Homatropine Methylbromide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0599-2018

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
03-05-2018
Reported
03-21-2018
Quantity
134,364 bottles (4,030,920 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79298
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novel Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-08-2020
Product Description About Product Description
Full technical description of the product.
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

43386-118-03 Hydrocodone Bitartrate And Homatropine Methylbromide
43386-118-01 Hydrocodone Bitartrate And Homatropine Methylbromide
43386-118-05 Hydrocodone Bitartrate And Homatropine Methylbromide