NDC 76420-126

Tadalafil 5 mg tablet, film coated

On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-370.

Where the pills inside were made

Factory	Where	Role	Last FDA inspection
Acme Generics Private Limited	Solan, India	Makes it and tests it	Problems found, fixed voluntarilyFeb 20, 2026 · 1 inspection
Intas Pharmaceuticals Limited	Ahmedabad, India	Makes it and tests it	Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action

Repackaging site

Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it

Recalls

Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;
Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041…
Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P210…
Feb 7, 2023 · Class II · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Lots: Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156…

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

Product details

Generic drug: Tadalafil: every company that makes it
Form: tablet, film coated, oral
Strength: 5 mg
Approval: ANDA ANDA209167
On the market since: Mar 27, 2019
Package NDCs: 76420-126-15 76420-126-30 76420-126-90
Official label: DailyMed (National Library of Medicine), updated Jan 28, 2022

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