The Recall Desk
ModerateFDA (Drugs)·D-1259-2020·Announced 2020-05-13

Sandoz Recalls Infuvite Pediatric Injection Due to Defective Container Crimping

Sandoz is recalling 17,500 units of Infuvite Pediatric Multiple Vitamins Injection due to sub-optimal crimping in the vial. The product was distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The defect is a container issue (crimping) rather than a direct contamination or mislabeling of the drug substance itself, and no injuries or illnesses are reported in the source text.

Plain-English summary

Sandoz, Inc. is recalling 17,500 units of Infuvite Pediatric (Multiple Vitamins Injection) due to a defective container. The specific defect identified is sub-optimal crimping in the vial. The affected product is identified by Lot # JX907 with an expiration date of 02/2021.

The recalled product is a prescription-only medication distributed by Baxter Healthcare Corporation Clintec Nutrition Division. It was distributed nationwide within the United States. The product consists of a kit containing a 40 mL fill in a 50 mL vial and a 10 mL vial.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION)
Brand
INFUVITE PEDIATRIC
Manufacturer
Sandoz, Inc
Affected units
17,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: JX907
  • Exp. Date 02/2021

Distribution

Distributed nationwide across the United States.