NDC 0409-3515
Vancomycin Hydrochloride 1.5 g injection, powder, lyophilized, for solution
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira, Inc. | McPherson, KS, United States | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJan 17, 2025 · 16 inspections, 2 with FDA action |
Recalls
- Dec 22, 2022 · Class I · Pfizer Inc.
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Lots: Lot: 33045BA, EXP 1SEP2023 - Aug 30, 2017 · Class I · Pfizer Inc.
Presence of Particulate Matter: glass particulate found in vial
Lots: Lot: 632153A; Exp. 03/18 - Nov 7, 2014 · Class III · Hospira Inc.
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Lots: Lot# 43-240-DD; Exp. 07/16 Lot# 44-205-DD,44-455-DD,44-460-DD,44-465-DD; Exp. 08/16 - Oct 6, 2014 · Class II · Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Lots: One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI - Oct 6, 2014 · Class II · Hospira Inc.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Lots: Lot #: 35-315-DD; Exp 1NOV2015
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Vancomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 1.5 g
- Approval
- ANDA ANDA062912
- On the market since
- May 28, 2021
- Package NDCs
0409-3515-010409-3515-11- Official label
- DailyMed (National Library of Medicine), updated Apr 1, 2026
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