Drug 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
D-0599-2018
Product summary
- Event
- Event 79298
- Status
- Terminated
- Classification
- Class III
- Quantity
- 134,364 bottles (4,030,920 tablets)
- Official record key
drug-enforcement:D-0599-2018
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications