Recalls / Class III
Class IIID-0145-2017
Product
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
- Brand name
- Ceftriaxone Sodium
- Generic name
- Ceftriaxone Sodium
- Active ingredient
- Ceftriaxone Sodium
- Route
- Intramuscular, Intravenous
- NDCs
- 0409-7332, 0409-7337, 0409-7338, 0409-7335
- FDA application
- ANDA065169
- Affected lot / code info
- Sandoz - Lot GJ7151(Pfizer- Lot 670028M); Exp. 07/19
Why it was recalled
Labeling: Missing Label
Recalling firm
- Firm
- Sandoz Inc
- Manufacturer
- Hospira, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, N/A, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 139,430 vials
- Distribution pattern
- WI
Timeline
- Recall initiated
- 2016-10-19
- FDA classified
- 2016-11-19
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-07-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0145-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.