Drug recall D-0599-2018
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
Reason for recall
Failed Impurities/Degradation Specifications
Lots and codes
M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019);
Recall details
- Recalling firm
- Novel Laboratories, Inc., Somerset, NJ
- Quantity
- 134,364 bottles (4,030,920 tablets)
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 5, 2018
- Terminated
- June 8, 2020
Related products
- Hydrocodone Bitartrate and Homatropine Methylbromide – drug information
- NDC 43386-118 Hydrocodone Bitartrate and Homatropine Methylbromide · Hydrocodone Bitartrate 5 mg/1; Homatropine Methylbromide… · Lupin Pharmaceuticals,Inc.