NDC 10544-512
Promethazine Hydrochloride 12.5 mg tablet
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-040.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Repackaging site
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages it
Recalls
- May 8, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Lots: Lot #: MN9081, Expiry: 09/2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Promethazine: every company that makes it
- Form
- tablet
- Strength
- 12.5 mg
- Approval
- ANDA ANDA040596
- On the market since
- Mar 30, 2010
- Package NDCs
10544-512-1010544-512-20- Official label
- DailyMed (National Library of Medicine), updated Aug 28, 2015
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