Recalls / Class I
Class ID-0184-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Brand name
- Vancomycin Hydrochloride
- Generic name
- Vancomycin Hydrochloride
- Active ingredient
- Vancomycin Hydrochloride
- Route
- Intravenous
- NDCs
- 0409-3515, 0409-6531, 0409-6533, 0409-4332
- FDA application
- ANDA062912
- Affected lot / code info
- Lot: 33045BA, EXP 1SEP2023
Why it was recalled
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 89,700 vials
- Distribution pattern
- USA nationwide and Puerto Rico
Timeline
- Recall initiated
- 2022-12-22
- FDA classified
- 2023-01-25
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-08-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0184-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.