NDC 52959-193

Naproxen 500 mg tablet

On the label: H.J. Harkins Co., Inc.. It's repackaged: H.J. Harkins Co., Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-190.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Glenmark Pharmaceuticals Limited	Goa, India	Makes it and tests it	Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action

H.J. Harkins Company, Inc., Grover Beach, California, United States · makes it, repackages it and relabels it

Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17231956, exp. date Aug-25
Nov 7, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Lots: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025
Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022
Aug 27, 2021 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022
Jul 6, 2012 · Class II · Glenmark Generics Inc., USA
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Lots: Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Naproxen: every company that makes it
Form: tablet
Strength: 500 mg
Approval: ANDA ANDA091416
On the market since: Jan 2, 2018
Package NDCs: 52959-193-00 52959-193-02 52959-193-06 52959-193-14 52959-193-20 52959-193-21 52959-193-28 52959-193-30 52959-193-40 52959-193-45 52959-193-60 52959-193-90
Official label: DailyMed (National Library of Medicine), updated Jan 26, 2023

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