Recalls / Class II
Class IID-1259-2020
Product
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0
- Brand name
- Infuvite Pediatric
- Generic name
- Multiple Vitamins Injection
- NDCs
- 54643-5646, 54643-5647
- FDA application
- NDA021265
- Affected lot / code info
- Lot #: JX907, Exp. Date 02/2021
Why it was recalled
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Recalling firm
- Firm
- Sandoz, Inc
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 17,500 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-04-21
- FDA classified
- 2020-05-01
- Posted by FDA
- 2020-05-13
- Terminated
- 2023-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1259-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.