Home / Recalls / Novel Laboratories, Inc. / D-0599-2018

D-0599-2018 Class III Terminated

Recalled by Novel Laboratories, Inc. — Somerset, NJ

Recall Details

Product Type: Drugs
Report Date: March 21, 2018
Initiation Date: March 5, 2018
Termination Date: June 8, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 134,364 bottles (4,030,920 tablets)

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

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

Nationwide

Code Information

M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);