NDC 21695-889

Diazepam 5 mg per 1 mL injection, solution

On the label: Rebel Distributors Corp... It's a repackaged product: Rebel Distributors Corp.. rebottles it from Hospira, Inc.'s NDC 0409-3213.

Where the pills inside were made

Hospira, Inc.

Rocky Mount, NC, United States · makes it, tests it, packages it and labels it

No problems found Last FDA inspection Feb 7, 2025. 11 inspections on record, 3 with serious problems.

Hospira, Inc.

McPherson, KS, United States · tests it

Problems found, fixed voluntarily Last FDA inspection Jan 17, 2025. 16 inspections on record, 2 with serious problems.

Recalls

• Aug 16, 2013 · Class II · Terminated
  Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
  Lots: Lot: 23-505-EV, Exp. 11/14
• May 16, 2013 · Class II · Terminated
  Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
  Lots: 17-099-EV Exp 05/14
• Feb 26, 2013 · Class II · Terminated
  Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
  Lots: Lot 05-585-EV Exp. 05/13
• Aug 28, 2012 · Class II · Terminated
  Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
  Lots: Lot 17-100-EV and 17-399-EV

Product details

Generic drug

Diazepam: see every company that makes it

Form

injection, solution

Strength

5 mg per 1 mL

Approval

ANDA ANDA071583

On the market since

Oct 13, 1987

Package NDCs

21695-889-10

Official label

DailyMed (National Library of Medicine), updated Dec 20, 2010

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