NDC 68788-8425

Pravastatin Sodium 10 mg tablet

On the label: Preferred Pharmaceuticals, Inc... It's repackaged: Preferred Pharmaceuticals, Inc.. 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

Repackaging site

Preferred Pharmaceuticals Inc., Anaheim, CA, United States · repackages it

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, oral
Strength: 10 mg
Approval: ANDA ANDA077987
On the market since: Apr 17, 2023
Package NDCs: 68788-8425-3 68788-8425-6 68788-8425-9
Official label: DailyMed (National Library of Medicine), updated Aug 17, 2026

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