Prescription drug
Where is Acetaminophen and Benzhydrocodone made?
2 companies sell it under their own name. Their labels name 3 factories in the United States.
United States 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Zevra Therapeutics, Inc. Apadaz325 mg / 4.08 mg, 325 mg / 6.12 mg, 325 mg / 8.16 mg · NDC 70040-0145, 70040-0167, 70040-0189 | Kvk-Tech, Inc.Makes it and packages it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
| Patheon Pharmaceuticals Inc.Makes it, tests it, packages it and labels it | Cincinnati, OH, United States | Problems found, fixed voluntarilySep 2025 | |
| Veranova, L.P.Makes the active ingredient | West Deptford, NJ, United States | Problems found, fixed voluntarilyJan 2026 | |
| KVK-TECH, Inc. Apadaz325 mg / 4.08 mg, 325 mg / 6.12 mg, 325 mg / 8.16 mg · NDC 10702-340, 10702-343, 10702-341 +3 | Kvk-Tech, Inc.Makes it | Newtown, PA, United States | Serious problems, FDA actionMar 2025 |
Recalls
- Dec 18, 2020 · Class III · KVK-Tech, Inc.
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.