TOPIC: Enoxaparin Sodium Injection USP by Apotex: Recall - Due to Mislabeling of Syringe Barrel Measurement Markings AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection USP due to a packaging error resulting in some syringe barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8 mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CS008, strength 100 mg/mL), if a patient used a 150 mg/mL concentration packaged in a barrel corresponding to a l00 mg/mL concentration, patients could receive 3.75 mg of enoxaparin, instead of 3 mg of enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8 mL), if a patient used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, patients would receive 2 mg of enoxaparin rather than 2.5 mg of enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternatively, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions. For more information about this recall click on the red button "Read Recall" below. BACKGROUND: Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), treatment of acute DVT, 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. RECOMMENDATION: Patients who have received either of the two (2) impacted batches, CS008 or CT003, of enoxaparin sodium Injection USP or have questions regarding this recall should contact their pharmacy. Patients should not interrupt their therapy, should immediately contact their health care provider for medical advice and should return the impacted product . Anyone with an existing inventory of the product should quarantine the recalled batches immediately. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. |
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