Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Vancomycin Hydrochloride for Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Affected NDCs
0409-3515-01
0409-3515-11
Compare with the code on your package — it is the most precise check available.
Drug: Vancomycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Vancomycin Hydrochloride NDC 00409-3515 |
1.5 g/1 | Injection, Powder, Lyophilized, for Solution Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0184-2023 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Vancomycin recalls
See all
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
Class II · Moderate risk
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
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Vial Label: Epinephrine Injection
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Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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