Class III · Low risk
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
FDA Drug Recalls
13 recalls · Class III, newest first
Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class III · Low risk
Prednisone 20 mg
Labeling: Not elsewhere classified. NDC number is incorrect on the container.
Class III · Low risk
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Class III · Low risk
Donnatal
Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.
Class III · Low risk
Lamivudine Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Class III · Low risk
Ampicillin Capsules
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Desmopressin Acetate Tablets
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
Labeling: Illegible label. Writing is rubbing off of labels.
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL