Recalls / Class II
Class IID-0564-2021
Product
Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70
- Brand name
- Cefazolin
- Generic name
- Cefazolin
- Active ingredient
- Cefazolin Sodium
- Route
- Intramuscular, Intravenous, Parenteral
- NDCs
- 0781-3450, 0781-3451
- FDA application
- ANDA062831
- Affected lot / code info
- JZ9830
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 8 vials
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0564-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.