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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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Dreambones, chicken variety cause seizures, Pittsburgh, PA, USA

January 19, 2021 10:19 PM

Pittsburgh, Pennsylvania, United States

My puppy Angus, at age 5 months, ate a small amount of a dream bone on Jan 9, 2020 in the afternoon, and then started crying and pacing, not eating any more. About 5 pm, he refused to eat, and went to lie down in his bed, not begging at our table while we ate. He seemed stiff, and lay down with his neck stretched out. Soon he was unresponsive and glassy-eyed, and stiff as a board. I took him to the Emergency vet, who did not think that there was any obstruction, and while at the vet's he improved, so I brought him home for observation. The vet said that it could be the onset of a neurological condition, or something in the Dreambone. He recovered, is now 18 months (it is more than a year later) and has never had a similar episode. By a process of elimination, it is probable that the Dreambone caused this reaction, and that it wasn't lethal because he only ate a small amount.

Reported By SafelyHQ.com User

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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.

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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

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Reported By SafelyHQ.com User