FDAFDA · Food and drugs·Recall number D-0599-2018
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
Published March 21, 2018 · Recall initiated: March 5, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
- Manufacturer
- Novel Laboratories, Inc.
- Distributor
- Nationwide
- UPC
- 0343386118038
- Lot
- M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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