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Class II: temporary or reversible health riskTerminated

Sandoz Infuvite PEDiatric Pharmacy Recall

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 m…

Sandoz, Inc · Princeton, NJ

Risk level
Class II
Reported by FDA
May 13, 2020
Recall ID
D-1259-2020
Check your lot numberHow we source this data

Summary

Sandoz recalled Infuvite PEDiatric Pharmacy starting Apr 21, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1259-2020 on May 13, 2020. Reason: Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins. Status: Terminated.

Why it was recalled

Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: JX907, Exp. Date 02/2021

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1259-2020
Classification
Class II
Status
Terminated
Recall initiated
Apr 21, 2020
FDA report date
May 13, 2020
Quantity
17,500 units
Recall type
Voluntary: Firm initiated
Recalling firm
Sandoz, Inc

Original FDA data

Every field from FDA enforcement report D-1259-2020, exactly as published.

Show all FDA fields
City
Princeton
State
NJ
Status
Terminated
Country
United States
Event ID
85538
Address
506 Carnegie Ctr Ste 400
Code information
Lot #: JX907, Exp. Date 02/2021
Postal code
08540-6243
Report date
May 13, 2020
Product type
Drugs
Recall number
D-1259-2020
Classification
Class II
Recalling firm
Sandoz, Inc
Product quantity
17,500 units
Termination date
Sep 7, 2023
Reason for recall
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide within the United States
Recall initiation date
Apr 21, 2020
Initial firm notification
Letter
Center classification date
May 1, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1259-2020, published May 13, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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