Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Infuvite PEDiatric Pharmacy (Multiple Vitamins Injection)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
54643-5647-00
Compare with the code on your package — it is the most precise check available.
Product details
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 Pediatric multiple vitamins injection NDC 54643-5647 |
Kit | Sandoz Inc | Rx |
- Recalling firm
- Sandoz, Inc
- NDC code
- 54643-5647-0
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1259-2020 · FDA notice
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.
Other recalls by Sandoz, Inc
All 2020 recalls
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Class I · High risk
Buffered Penicillin G Potassium for Injection
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Other packaging defect recalls from 2020
All packaging defect recalls
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class III · Low risk
Desflurane
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class II · Moderate risk
Albuterol Sulfate Inhalation Aerosol
Defective Delivery System: Sustained trend of failure to dispense complaints.
Class II · Moderate risk
Cetrotide (cetrorelix acetate for Injection)
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
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