NDC 53808-0764
Pravastatin Sodium 10 mg tablet
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-195.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USA | Monroe, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyJun 17, 2025 · 2 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-26 - Jun 28, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: results below specifications
Lots: Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290… - Mar 25, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Lots: Lot 17181491 Exp. Aug. 2021 - Apr 5, 2013 · Class III · Glenmark Generics Inc., USA
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
Lots: Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 E…
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
- Strength
- 10 mg
- Approval
- ANDA ANDA077987
- On the market since
- Jul 1, 2009
- Package NDCs
53808-0764-1- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2010
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