NDC 67296-0516
Promethazine with Codeine 10 mg per 5 mL / 6.25 mg per 5 mL solution
On the label: RedPharm Drug. Inc.. It's repackaged: RedPharm Drug. Inc. rebottles it from Morton Grove Pharmaceuticals, Inc.'s NDC 60432-606.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Morton Grove Pharmaceuticals, Inc. | Morton Grove, Illinois, United States | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 5, 2016 · 6 inspections, 1 with FDA action |
Repackaging site
- Unit Dose Solutions, Inc., Raleigh, NC, United States · labels it and repackages it
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.
Lots: Lot #: UV1198
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Codeine and Promethazine: every company that makes it
- Form
- solution
- Strength
- 10 mg per 5 mL / 6.25 mg per 5 mL
- Approval
- ANDA ANDA088875
- On the market since
- Jan 1, 2021
- Package NDCs
67296-0516-1- Official label
- DailyMed (National Library of Medicine), updated Jan 1, 2021
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