Class III · Low risk
Tramadol Hydrochloride 50 mg tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
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 III · Low risk
Indomethacin Capsules USP
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class I · High risk
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Class III · Low risk
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class II · Moderate risk
Coppertone Kids Sunscreen Spray
Labeling: Label mix-up
Class II · Moderate risk
Fluconazole Injection
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class III · Low risk
Klonopin (clonazepam)
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class II · Moderate risk
Mycamine (micafungin)
Labeling: Label Error on Declared Strength
Class III · Low risk
Oxycodone Hydrochloride Tablets
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class I · High risk
Senna Laxative
Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.
Class II · Moderate risk
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV
Labeling: Label Error on Declared Strength
Class I · High risk
Clopidogrel Tablets
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
Class II · Moderate risk
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class III · Low risk
Enoxaparin Sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Class II · Moderate risk
Gabapentin Tablets
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Class II · Moderate risk
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg)
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Class II · Moderate risk
7-Keto DHEA 25mg Capsule
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
7-Ketodehydroepiandrosterone
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
Vitamin 10 B Lyophilized Vial
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
Vitamin 9 A/B Lyophilized Vial
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
Vitamin 9 Lyophilized Vial
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
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 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
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 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
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL)
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.
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