Recall: D-0836-2018
Class III - Minor Violations
Class IIIClassification
2018-05-24Initiated
TerminatedStatus
LUPIN SOMERSETFirm
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Reason
Labeling: Missing Label
Distribution
OH
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.