Opioid Agonist
Where is Hydrocodone and Methylhomatropine made?
7 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 4 factories in the United States.
United States 4
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Genus Lifesciences Inc.5 mg / 1.5 mg, 5 mg per 5 mL / 1.5 mg per 5 mL · NDC 64950-206, 64950-371 | Genus Lifesciences Inc.Makes it | Allentown, PA, United States | No problems foundJul 2024 |
| Genus Lifesciences Inc.Makes it | Allentown, PA, United States | Problems found, fixed voluntarilyDec 2024 | |
| Akorn5 mg per 5 mL / 1.5 mg per 5 mL · NDC 50383-043 | AkornMakes it | Location not on file | Not inspected on record |
| KVK-TECH, Inc.5 mg / 1.5 mg, 5 mg per 5 mL / 1.5 mg per 5 mL · NDC 10702-055, 10702-150 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Lupin Pharmaceuticals, Inc.5 mg / 1.5 mg · NDC 43386-118 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Novel Laboratories, Inc.5 mg / 1.5 mg, 5 mg per 5 mL / 1.5 mg per 5 mL · NDC 40032-118, 40032-810 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Bio-Pharm, Inc.5 mg per 5 mL / 1.5 mg per 5 mL · NDC 59741-262 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Pharmaceutical Associates, Inc.5 mg per 5 mL / 1.5 mg per 5 mL · NDC 0121-1036 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydrocodone and Methylhomatropine 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.
- Atlantic Biologicals Corps.:
17856-0043,17856-0455 - Dispensing Solutions Inc.:
66336-871
Recalls
- Apr 27, 2021 · Class III · KVK-Tech, Inc.
Failed Impurities/Degradation Specifications - Nov 1, 2019 · Class II · KVK-Tech, Inc.
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection - May 21, 2019 · Class II · Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). - Mar 5, 2018 · Class III · Novel Laboratories, Inc.
Failed Impurities/Degradation Specifications
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.