NDC 0409-0010 – Propofol
Propofol 10 mg/mL · Injection, Emulsion · Intravenous
Product NDC0409-0010
Product details
- Brand name
- Propofol
- Generic name
- Propofol
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Emulsion
- Route
- Intravenous
- Marketing category
- ANDA · ANDA077908
- Marketed since
- August 17, 2026
- Listing expires
- December 31, 2027
- Pharmacologic class
- General Anesthetic
Active ingredients
- Propofol 10 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0409-0010-98 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0010-98) / 100 mL in 1 VIAL, SINGLE-DOSE (0409-0010-97) | Aug 17, 2026 |
Recalls mentioning this NDC
- D-1540-2022 Sep 21, 2022 · Class I
Presence of particulate matter - D-1301-2022 Aug 3, 2022 · Class I
Presence of particulate matter: particulate identified as a beetle. - D-0389-2015 Feb 25, 2015 · Class I
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. - D-0381-2015 Feb 4, 2015 · Class II
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron. - D-1547-2014 Aug 27, 2014 · Class I
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and… - D-1033-2014 Jan 29, 2014 · Class II
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential… - D-66637-001 Nov 13, 2013 · Class II
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. - D-932-2013 Sep 18, 2013 · Class II
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. - D-887-2013 Aug 21, 2013 · Class II
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel - D-297-2013 May 1, 2013 · Class II
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
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