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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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First Moderna Shot, Novi, MI, USA

February 11, 2021 4:59 PM

Novi, Michigan, United States

Symptoms: Dizziness Soreness

The wait was about an hour and a half, and we had to stand outside. The shot was easy and simple. They will make you wait for 15-30 minutes for any side effects. I felt slightly dizzy and hot. I was sore for the next few days,but that was it.

Reported By SafelyHQ.com User

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62.4-oz. (3-lbs. 14.4-oz.) heat and serve container of “HyVee mealtime CHICKEN ENCHILADAS” with lot code “21003” and “Best If Use By: 01/10/2021” date on the product label. The products bear establishment number “P51558” inside the USDA mark of inspection. These items were distributed to HyVee retail locations in Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin.

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“Company name: Apotex Corp
Brand name: Apotex Corp.
Product recalled: Enoxaparin Sodium Injection, USP
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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

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 NumberOn 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 batches of Enoxaparin Sodium Injection, USP were distributed by Apotex nationwide in the USA to Wholesalers and Warehousing Chains. Apotex Corp. is currently notifying its affected direct account Wholesalers and Warehousing Chains, via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Check the full recall details on fda.gov

Source: FDA
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Indianapolis, IN, USA

February 2, 2021 10:30 PM

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February 23, 2021 1:16 PM

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