NDC 71610-165

Buspirone Hydrochloride 5 mg tablet

On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-200.

Where the pills inside were made

Repackaging site

• Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it

Recalls

• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024;
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024;
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: P2105483, Exp. Date 7/31/2024;
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: P2105472, Exp. Date 4/30/2024;
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: P2105551, Exp. Date 7/31/2024;

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

Product details

Generic drug

Buspirone: every company that makes it

Form

tablet, oral

Strength

5 mg

Approval

ANDA ANDA202557

On the market since

Dec 15, 2016

Package NDCs

71610-165-53 71610-165-60 71610-165-80

Official label

DailyMed (National Library of Medicine), updated Oct 18, 2018

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