Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
FDA Drug Recalls
70 recalls, newest first
Class II · Moderate risk
Carvedilol Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Acyclovir Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class I · High risk
FENTANYL Transdermal System
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class III · Low risk
Clonidine HCL Injection
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Gavilyte-N
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk
Drospirenone and Ethinyl Estradiol Tablets
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk
MAGnesium 2 gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 2gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 1gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
Labetalol 20mg
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class III · Low risk
Mometasone Furoate Cream
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class II · Moderate risk
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL
Labeling: Incorrect expiration date.
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk
NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag
Labeling: Label mix-up
Class II · Moderate risk
NORepinephrine 16 mg added to 0.9% Sodium Chloride
Labeling: Label mix-up
Class II · Moderate risk
Docusate Sodium
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Class II · Moderate risk
HEPERAIN 50 mg/50 mL
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)