Class II · Moderate risk
Early TPN (Neonatal)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Labeling errors & mix-ups
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.
1,411 FDA drug recalls with this cause, newest first.
This is exactly what it sounds like: the wrong label on the right product, the wrong strength printed on the bottle, a missing or illegible lot number and expiry date, or two products mixed up during packaging. It is dangerous precisely because the pill or liquid itself may be fine, yet the patient has no way of knowing what they are actually taking. A high share of the Class I recalls in this group are mix-ups where a stronger product ended up in a weaker product's packaging.
Class II · Moderate risk
Standard Starter TPN all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
TPN Neonatal all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
NICU STARTER TPN all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ropi/ Epi/ Clon PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ofirmev (Acetaminophen)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
NOVA PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
RECK PeriCapsular injection all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Nalbuphine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Lidocaine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ropivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Bupivacaine HCl in 0.9% Sodium Chloride all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class III · Low risk
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium PHOSphate added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class II · Moderate risk
Potassium PHOSphate in 0.5% Dextrose
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Potassium CHLORide added to 0.9% Sodium Chloride
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Labeling: Incorrect or Missing Lot and/or Exp Date
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