NDC 53217-216

Lorazepam 0.5 mg tablet

On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Leading Pharma, LLC's NDC 69315-904.

Where the pills inside were made

Recalls

• Jan 21, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
  Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
  Lots: Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026.
• Sep 28, 2017 · Class II · Leading Pharma, LLC
  Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
  Lots: Lot #E00717

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

Product details

Generic drug

Lorazepam: every company that makes it

Form

tablet

Strength

0.5 mg

Approval

ANDA ANDA078203

On the market since

Oct 1, 2007

Package NDCs

53217-216-15 53217-216-30 53217-216-45 53217-216-60 53217-216-90

Official label

DailyMed (National Library of Medicine), updated Nov 29, 2016

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