Class III · Low risk
FOLLOW YOUR DREAMS! Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
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
Girls can change the World
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
Shine from within blueberry Anti bac Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
Share a Smile Mixed berry Anti bac Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class III · Low risk
Believe in Yourself Strawberry Anti bac Justice
Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Class I · High risk
Enteric Coated Aspirin
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Class III · Low risk
Prednisone Tablet USP
Labeling: Missing Label; missing label on blister card
Class II · Moderate risk
Zolpidem Tartrate Tablets 5 mg
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Class II · Moderate risk
Pure-Aid Allergy Relief
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Class II · Moderate risk
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Class II · Moderate risk
Ropinirole hydrochloride tablets
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Class II · Moderate risk
Walmart Amlodipine Besylate Tablets
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Class III · Low risk
Lamisil AT
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Class II · Moderate risk
Pentrexcilina Jarabe NF
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Class II · Moderate risk
Pentrexcilina
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Class III · Low risk
Lisinopril Tablets
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Class III · Low risk
Lorazepam
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Class II · Moderate risk
Children's Acetaminophen Oral Suspension
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
Class III · Low risk
Tizanidine Tablets USP
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Class II · Moderate risk
Donnatal Extentabs
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
Class III · Low risk
4 way Saline Moisturizing Mist with Eucalyptol & Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
4 way Nasal Decongestant Menthol Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
4 way Nasal Decongestant Fast Acting Nasal Spray
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
Nupercainal
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Class III · Low risk
Myoflex (trolamine salicylate)
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
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