Novel Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0599-2018 | Class III | Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets | March 5, 2018 |
| D-0653-2017 | Class III | Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 | February 22, 2017 |
| D-1484-2014 | Class III | Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Inject | June 20, 2014 |