Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Thyro-Tab 0.088 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Levothroid
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Thyro-Tab 0.050 mg.
cGMP Deviations; does not meet in process specification requirements
Class II · Moderate risk
Naproxen Tablets USP
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Class III · Low risk
Hydroxyzine Hydrochloride Oral Solution
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Class III · Low risk
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Class II · Moderate risk
Leucovorin Calcium Injection USP
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class III · Low risk
Nexium (esomeprazole magnesium)
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Class II · Moderate risk
Mercaptopurine Tablets
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Class II · Moderate risk
Mylan
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Class III · Low risk
Famotidine Tablets USP
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Class III · Low risk
Super Colon Cleanse
Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Class II · Moderate risk
Paclitaxel Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Methotrexate Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Cytarabine Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class II · Moderate risk
Carboplatin Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Class I · High risk
Vecuronium Bromide for Injection
Presence of Particulate Matter
Class III · Low risk
Lactated Ringer's Injection
CGMP Deviations: Shipment of product not approved for release.
Class II · Moderate risk
Oxygen
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
Class II · Moderate risk
Little Remedies For Tummys
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
Class III · Low risk
Tobramycin Ophthalmic Oint.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Class II · Moderate risk
Dukal Corporation BZK Swab
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Class II · Moderate risk
ZEE Antiseptic Wipes
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)