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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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Pfizer 1 can, Benton City, WA, USA

February 15, 2021 4:56 PM

Benton City, 99320 Washington, United States

Symptoms: Fatigue Soreness

Sore arm at injection site, next day soreness moving my arm. Also next day feeling tired.

Reported By SafelyHQ.com User

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Recent Interesting Reports

February 3, 2021 1:00 PM

“Company name: Apotex Corp
Brand name: Apotex Corp.
Product recalled: Enoxaparin Sodium Injection, USP
Reason of the recall: Packaging error resulting in incorrect dosage listed
FDA Recall date: February 03, 2021
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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 consumer 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/0.8mL), if a consumer 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. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.

Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), 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 affected Enoxaparin Sodium Injection, USP can be identified by NDC numbers stated on carton and label of the product.

Product: Enoxaparin Sodium Injection, USP
Batch #: CS008
Strength: 100 mg/mL
Syringe Barrel Measurement Markings: 100 mg/mL
Pack Size: 10 x 1mL Single Dose Syringes
NDC NumberOn Carton: 60505-0795-4
NDC Number On label: 60505-0795-1
UPC Code on Carton: 360505079544
UPC Code on label: (01)10360505079510

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NDC Number On label: 60505-0796-0
UPC Code on Carton: 360505079643
UPC Code on label: (01)10360505079602

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Product was distributed Nationwide in the USA to 1 e-commerce website amazon.com, distributors and retail stores. NDAL MFG INC has notified its distributors and customers by e-mail followed by telephone and further email and has arranged for return/replacement etc. of all recalled products. 

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Doctor Visit: Yes
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