Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Recalls
- Jul 11, 2017 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Lots: Lot #: a) C700220, Exp 06/18; b) C700220, Exp 06/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Pravastatin: every company that makes it
- Form
- tablet, oral
- Strength
- 80 mg
- Approval
- ANDA ANDA076714
- On the market since
- Dec 31, 2009
- Package NDCs
55111-274-0155111-274-0555111-274-3055111-274-90- Official label
- DailyMed (National Library of Medicine), updated Nov 21, 2018
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