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.
FDA drug recalls in 2012
Every FDA drug recall initiated in 2012, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
534 recalls, newest first.
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)
Class II · Moderate risk
Kleenex Foam Hand Sanitizer
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Class II · Moderate risk
Kleenex Luxury Foam Hand Sanitizer
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Class III · Low risk
Erythromycin Topical Solution USP
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
Class II · Moderate risk
Diazepam Injection
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Class III · Low risk
Pitocin (Oxytocin Injection, USP)
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Class II · Moderate risk
Kombiglyze XR
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.