Class II · Moderate risk
Human Chorionic Gonadotropin 2
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Estriol 0.1%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Bi-Est (Estriol/Estradiol)
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Anastrozole SR 1 mg Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Anastrozole 0.5 mg Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class III · Low risk
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class I · High risk
Midazolam Injection
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Class II · Moderate risk
Succinylcholine 20 MG/ML INJ
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class III · Low risk
Clofarabine injection
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class III · Low risk
Clolar (clofarabine)
Labeling: Incorrect or Missing Package Insert.
Class II · Moderate risk
Lorazepam Tablets
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Class III · Low risk
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Ampicillin for Injection
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class III · Low risk
Mobic (meloxicam)
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
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