FDA – On February 03, 2021, the FDA published a recall announcement reporting that Apotex Corporation has issued a nationwide recall of its Enoxaparin Sodium Injection, USP, due to a mislabeling error that affected the syringe’s barrel measurement markings. According to the FDA, this is a serious issue that warrants a recall because the packaging error could result in an “incorrect dosage listed.”
Apotex Corp is announcing the recall of two (2) lots of Enoxaparin Sodium Injection, USP sold at the consumer level due to a dangerous packaging error. The error could result in some syringes barrels listing 150 mg/mL markings (and also incorrectly corresponding to 120 mg/0.8mL concentration) instead of the correct 100 mg/mL markings (that correspond with the 100 mg/mL concentration) on the syringe barrel. This packaging error was detected through a customer complaint investigation. Apotex stated that the company had not received any adverse event reports that are related to using the recalled batches. The recalled syringes are manufactured by Gland Pharma Limited in Hyderabad, India.
What is Enoxaparin Sodium Used For?
Enoxaparin Sodium Injection is used for the prophylaxis of deep vein thrombosis (DVT), and for the “treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina, and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.”
The Dangers Associated with the Enoxaparin Sodium Injection, USP
Incorrect Syringe Barrel Markings
The labeling error might lead to dosing miscalculations, dosing errors, and inaccurate dose administration causing harm to patients. If a patient is accidentally given a recalled batch (batch CS008, strength 100 mg/mL), which contains a 150 mg/mL concentration, a patient might receive 3.75 mg of Enoxaparin instead of 3 mg. If a patient accidentally overdoses with Enoxaparin sodium, he or she could develop a bleeding complication. If a patient’s dose is less than what has been prescribed, the patient could develop a blood clotting condition.
How to Identify the Recalled Enoxaparin Sodium Injection
The recalled Enoxaparin Sodium Injection USP is identifiable by the National Drug Code numbers written on the product’s carton and on the product’s label. (See Below).
Product: Enoxaparin Sodium Injection, USP
Batch # CS008
Syringe Barrel Measurement Markings: 100 mg/mL
Pack Size: 10 x 1mL Single Dose Syringes
NDC Number on Carton: 60505-0795-4
NDC Number on Label: 60505-0795-1
UPC Code on Carton: 360505079544
UPC Code on Label: (01)10360505079510
Product: Enoxaparin Sodium Injection, USP
Batch # CT003
Strength: 120 mg/0.8mL
Syringe Barrel Measurement Markings: 150 mg/ mL
Pack Size: 10 x 0.8 mL Single Dose Syringes
NDC Number on Carton: 60505-0796-4
NDC Number on Label: 60505-0796-0
UPC Code on Carton: 360505079643
UPC Code on Label: (01)10360505079602
The two (2) affected lots of Enoxaparin Sodium Injection, USP were distributed nationwide by Apotex to Warehousing Chains and Wholesalers. Apotex Corp. is notifying all affected direct account Warehousing and Wholesalers Chains. The recall notification letter includes a recall notification letter and instructions on how to arrange for the return of all recalled drugs.
Patients who were given one of the two (2) impacted batches of Enoxaparin Sodium Injection, USP, or have questions concerning this recall should talk to their pharmacy. Patients should not halt their therapy but should immediately call their treating physician for instructions on what to do.
Distributors, Wholesalers, and Retailers are asked to return the recalled syringes to the place of purchase urgently. Clinics or hospitals that have an existing inventory of the recall products should immediately quarantine those recalled lots. Customers who bought the affected Enoxaparin Sodium Injections directly from Apotex may contact call Inmar Rx Solutions to prepare their return.
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