Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations: Products were stored outside the drug label specifications.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Compare with the code on your package — it is the most precise check available.
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Infuvite Adult multiple vitamins injection NDC 54643-5649 |
Kit | Sandoz Inc | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
CGMP Deviations; potential temperature excursions due to transit delays
CGMP Deviations; potential temperature excursions due to transit delays
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
LABELING: LABEL MIX-UP
LABELING: LABEL MIX-UP
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
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