Alcon Laboratories: Foreign Material Found Inside A Sealed Single-Use Vial
Date: 12/23/2024
Reason for Recall: Alcon Laboratories has issued a voluntary nationwide recall of one lot of Systane Lubricant Eye Drops Ultra PF, specifically the Single Vials On-the-Go, 25 count (Lot 10101), due to concerns over fungal contamination. This decision was prompted by a consumer complaint regarding foreign material found inside a sealed single-use vial, which was later identified as fungal in nature.
Health Risks: Fungal contamination in ophthalmic products can lead to serious eye infections, which may be vision-threatening and, in rare cases, life-threatening for immunocompromised individuals.
Product Description: Lubricant Eye Drugs.
Par Pharmaceutical: Mislabeled with the incorrect strength on the carton
Date: 11/19/2024
Reason for Recall: Mislabeling occurred due to an error by a third-party packager, although the blister strips and tablets inside reflect the correct strength of 0.25 mg.
Health Risks: Inadvertently taking a higher dose can lead to serious side effects, including sedation, confusion, dizziness, and potentially life-threatening respiratory depression, especially in vulnerable populations.
Product Description: Clonazepam Orally Disintegrating Tablets, USP (C-IV).
STASKA Pharmaceuticals Inc: Presence of glass particulates
Date: 11/16/2024
Reason for Recall: Staska Pharmaceuticals, Inc. has issued a voluntary nationwide recall of one lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, specifically in 50mL vials. This recall was initiated due to the presence of glass particlesin the product, which poses significant health risks if administered.
Health Risks: The presence of glass particulates can lead to local irritation or swelling upon injection. More critically, these particles may travel through the bloodstream and potentially block blood vessels in vital organs, leading to serious complications such as stroke or even death.
Product Description: Ascorbic Acid Solution for Injection.
Gilead Sciences, Inc: Due to Presence of Glass Particle
Date: 9/23/2024
Reason for Recall: Gilead Sciences has announced a voluntary nationwide recall of one lot of Veklury (remdesivir) for Injection 100 mg/vial due to the discovery of a glass particle in a vial. This action was prompted by a customer complaint that led to an investigation confirming the contamination.
Health Risks: The presence of glass particles in injectable medications can pose serious health risks, including local irritation, swelling, and potentially severe complications if particles enter the bloodstream. This could lead to blockages in vital organs, resulting in strokes or even death. To date, Gilead has reported no adverse events associated with this recall.
Product Description: Veklury (remdesivir) for Injection.
B. Braun Medical Inc: Potential for particulate matter and fluid leakage of the containers
Date: 8/8/2024
Reason for Recall: B. Braun Medical Inc. has issued a voluntary nationwide recall of two lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers due to the potential for particulate matter and fluid leakage.
Health Risks: The presence of particulate matter in injectable solutions can lead to serious health risks, including potential embolic phenomena such as stroke or ischemia, and infections if the particulates are not sterile. Fluid leakage may also lead to contamination with microorganisms, posing further risks to patient safety.
Product Description: 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers.
Aurobindo Pharma USA, Inc.: Mislabeling
Date: 7/24/2024
Reason for Recall: The recall was initiated because the product lacked the required manufacturer labeling, which is essential for providing consumers with critical information regarding dosage and usage.
Health Risks: The product lacks the required Over the Counter (OTC) labeling information, drug facts and patient usage information. There is significant risk of misuse which could result in permanent liver damage if consumers exceed the recommended dose, combine use with excessive consumption of alcohol or are allergic to the active ingredient which could be life-threatening.
Product Description: Migraine Relief Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets
Par Pharmaceutical: Mislabeled with the incorrect strength on the carton
Date: 7/17/2024
Reason for Recall: The recall was initiated because some cartons were printed with incorrect strength and National Drug Code (NDC) codes, although the blister strips and tablets inside correctly reflect the intended strength of 0.25 mg. This error occurred during packaging by a third-party vendor.
Health Risks: Patients who inadvertently take a higher dose than prescribed may experience serious side effects, including sedation, confusion, dizziness, and potentially life-threatening respiratory depression, particularly in vulnerable populations.
Product Description: Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets.
American Health Packaging: Because of failed dissolution
Date: 6/26/2024
Reason for Recall: The capsules may not dissolve as intended, potentially resulting in dangerously high potassium levels.
Health Risks: Hyperkalemia can lead to severe complications such as irregular heartbeats, muscle weakness, and even death, particularly in patients with underlying health conditions such as hypertension or renal dysfunction.
Product Description: Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count.
Glenmark Pharmaceuticals, Inc: Because of failed dissolution
Date: 6/25/2024
Reason for Recall: Glenmark Pharmaceuticals Inc. has announced a voluntary nationwide recall of 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq Kdue to failed dissolution.
Health Risks: The failed dissolution of these capsules may result in elevated potassium levels in patients, particularly those with underlying conditions such as hypertension, heart failure, or kidney dysfunction. Hyperkalemia can cause severe adverse effects ranging from asymptomatic to life-threatening conditions like cardiac arrhythmias and muscle weakness.
Product Description: Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count.
Sagent Pharmaceuticals: Potential presence of particulate matter
Date: 5/29/2024
Reason for Recall: Sagent Pharmaceuticals has issued a voluntary nationwide recall of two lots of Docetaxel Injection, USP due to concerns regarding the potential presence of particulate matter. This action was prompted by a customer complaint about particulate contamination originating from the stopper in the drug product.
Health Risks: Healthcare providers and facilities are advised to:
- Immediately quarantine and discontinue use of the recalled lots.
- Return the recalled products as instructed in communications sent by Sagent Pharmaceuticals via FedEx.
- Notify any customers who may have received these products.
Product Description: Docetaxel Injection, USP
Hospira Inc: Potential Packaging Defect
Date: 5/22/2024
Reason for Recall: Incomplete crimp seals may lead to leakage, which could compromise the therapeutic effect of the medication and increase the risk of systemic infection.
Health Risks: If affected products are administered, there is a potential risk for lack of therapeutic effect and systemic infection that may necessitate additional medical treatment. To date, no adverse events related to this issue have been reported.
Product Description: Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units.
Eugia US LLC: Presence of Particulate Matter
Date: 3/28/2024
Reason for Recall: Eugia US LLC (formerly AuroMedics Pharma LLC) has issued a voluntary nationwide recall of one lot of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) due to the presence of white particles found in the vials.
Health Risks:The presence of white particles can lead to local irritation or swelling at the injection site. More critically, if these particles enter the bloodstream, they may travel to vital organs, potentially blocking blood vessels in the heart, lungs, or brain, which could result in serious complications such as stroke or death. As of now, Eugia has not received any reports of adverse events related to this issue.
Product Description: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial).
Azurity Pharmaceuticals, Inc: Mislabeled package
Date: 1/25/2024
Reason for Recall: A Nebraska pharmacist discovered that a bottle labeled as Zenzedi contained carbinoxamine maleate, an antihistamine, instead of the intended dextroamphetamine sulfate. This mislabeling poses significant risks, especially for patients requiring the stimulant for ADHD or narcolepsy treatment.
Health Risks:Consuming carbinoxamine maleate instead of Zenzedi can lead to sedation, sleepiness, and central nervous system depression. For patients with ADHD or narcolepsy, this could result in unmanaged symptoms and increase the risk of accidents or injuries.
Product Description: dextroamphetamine sulfate tablets, 30 mg.
