NDC 52959-534
Promethazine Hydrochloride 25 mg tablet
On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-041.
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 |
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
- 25 mg
- Approval
- ANDA ANDA040596
- On the market since
- Dec 14, 2005
- Package NDCs
52959-534-0052959-534-0152959-534-0252959-534-1052959-534-1252959-534-1552959-534-2052959-534-2452959-534-2852959-534-3052959-534-4552959-534-60- Official label
- DailyMed (National Library of Medicine), updated Apr 18, 2012
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