Novel Laboratories, Inc. recalls Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Nov
Recalled March 21, 2018 · FDA recall D-0599-2018 · Novel Laboratories
Hazard
Failed Impurities/Degradation Specifications · FDA Class III
Units
134,364 bottles (4,030,920 tablets)
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications
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
Manufacturer(s)
Novel Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →