Opioid Agonist, Phenothiazine
Where is Codeine and Promethazine made?
6 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 5 factories in the United States.
United States 5
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Cosette Pharmaceuticals, Inc.10 mg per 5 mL / 6.25 mg per 5 mL · NDC 0713-0823 | Tris Pharma IncMakes it, tests it and packages it | Monmouth Junction, NJ, United States | Problems found, fixed voluntarilyNov 2025 |
| H.J. Harkins Co., Inc.10 mg per 5 mL / 6.25 mg per 5 mL · NDC 52959-118 | H.J. Harkins Company, Inc.Makes it, repackages it and relabels it | Grover Beach, California, United States | Problems found, fixed voluntarilyMar 2023 |
| Morton Grove Pharmaceuticals, Inc.10 mg per 5 mL / 6.25 mg per 5 mL · NDC 60432-606 | Morton Grove Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | Morton Grove, Illinois, United States | Serious problems, FDA actionFeb 2016 |
| Nostrum Laboratories, Inc.10 mg per 5 mL / 6.25 mg per 5 mL · NDC 70408-185 | Nostrum Laboratories, Inc.Makes it, tests it and packages it | Bryan, Ohio, United States | Problems found, fixed voluntarilyMar 2025 |
| Quagen Pharmaceuticals LLC10 mg per 5 mL / 6.25 mg per 5 mL · NDC 70752-139 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Cranbury Pharmaceuticals, LLC10 mg per 5 mL / 6.25 mg per 5 mL · NDC 27808-065 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Codeine and Promethazine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-4127 - Aidarex Pharmaceuticals LLC:
33261-391 - Apotheca, Inc.:
12634-907,12634-909 - Atlantic Biologicals Corps.:
17856-0804,17856-1585,17856-0605,17856-0139+1 - Bryant Ranch Prepack:
72162-2042 - Direct Rx:
72189-486 - Lohxa:
70166-555 - Physicians Total Care, Inc.:
54868-1029 - Rebel Distributors Corp..:
21695-336,42254-140 - RedPharm Drug. Inc.:
67296-0516 - Unit Dose Services:
50436-1029
Recalls
- Sep 3, 2021 · Class II · Morton Grove Pharmaceuticals, Inc.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.