FDA-Drug2018-03-21Class III
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
Novel Laboratories, Inc.
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide
Affected count
134,364 bottles (4,030,920 tablets)
Manufactured in
400 Campus Dr, Somerset, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0599-2018Don't want to check this manually?
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