NDC 52959-204
Carvedilol 12.5 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 68462-164.
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 |
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Aug 7, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Lots: Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026 - Aug 7, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Lots: Lot#:19243202, Exp: 7/31/2026. - Aug 7, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Lots: Lot#:19243104, Expires: 7/31/2026. - Aug 6, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lots: Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026 - Aug 6, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Lots: Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-26 - Feb 28, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots: [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Ex… - Feb 28, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots: [100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,… - Feb 28, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots: Lot, Exp: Lots 19231899, 19231922, 19231927, 19231967, 19231979, Exp Apr-25; Lots 19232226, 19232234, 19232265, 1923227,1 Exp May-25; Lots 19232758, 19232759, 19232762, 19232788, Exp Jun-25 - Feb 28, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Lots: Lot, expiry: Lots 19231107, 19231114, 19231152, Exp Feb-25; Lot 19234866, Exp Jan-26 - Jan 22, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Lots: Lot numbers: a) 17230500, 17230509,17230526,17230546,17230551,17230603,17230628, 17230642,17230645,17230681, Exp.:02/2025; 17230829,17230832,17230854, 17230864,17230874,17230876,17230889,17230894, Exp.: 03/2025; 17230960, 17230964,17230976,17230981,17230985,17231161,17231171, Exp.: 04/2025 17231315… - Jan 22, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Lots: Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 1…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carvedilol: every company that makes it
- Form
- tablet
- Strength
- 12.5 mg
- Approval
- ANDA ANDA078251
- On the market since
- Sep 5, 2007
- Package NDCs
52959-204-30- Official label
- DailyMed (National Library of Medicine), updated Dec 8, 2011
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