Partial Heparin recall issued due to risk of serious adverse reaction
Baxter Healthcare has issued a nationwide Heparin recall for nine batches of their 1,000 units per millileter Heparin Sodium Injection in multi-dose vials. Over the past two weeks, Baxter has received over 100 reports of unusual alergic reactions, and at least one death which could be linked to the recalled Heparin.
>>FDA ALERT: Baxter Heparin Recall
Heparin is a blood thinning drug which is often used for patients undergoing open-heart surgery, vascular surgery, dialysis and a number of other medical procedures. There have been reports of patients experiencing severe alergic-type reactions to the apparently bad batch of Heparin sold by Baxter Healthcare. Some of the unusual reactions reported in patients who received the Heparin Sodium injection have included:
- Abdominal pain, Chest pain or stomach discomfort
- Burning sensation or restlessness
- Diarrhea, nausea or vomiting/retching
- Flushing, Dizziness and Headaches
- Drug ineffectiveness
- Pain upper middle part of the stomach (Dyspepsia)
- Shortness of breath or difficulty breathing (Dyspnea)
- Redness of the skin (Erythema)
- Increased sweating or perspiration (Hyperhidrosis)
- Reduced sense of touch or sensation (Hypoesthesia)
- Abnormally low blood pressure (Hypotension)
- Increased production of tears (Lacrimation)
- Loss of consciousness
- Malaise, Pallor or Heart Palpitations
- Tingling, pricking or numbness of the skin (Paresthesia)
- Swelling of the throat (Pharyngeal edema) or Thirst
- Rapid beating of the heart (Tachycardia)
- Lock jaw (Trismus)
- Unresponsiveness to stimuli
On January 17, 2008 Baxter sent a recall letter to their customers, wholesalers and distributes who received the affected Heparin Sodium 1000 unit/mL for injection. Although the letter indicated that they had not received any reports involving fatality, there are now reports out of Florida that a heart surgery patient died as a result of unusual postoperative blood clots on January 18th when the Heparin injection was apparently ineffective.
The Heparin recall applies to certain vials with expiration dates between September 2009 and November 2009 from the following Lot Numbers: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111. These Heparin vials should not be used and should be segregated from other vials.
There does not appear to be any connection between the Baxter Heparin recall and a recent recall of prefilled Heparin Syringes. The Heparin syringe recall, which was expanded last week to include both prefilled Heparin and Saline syringes, was issued because the syringes may be contaminated with Serratia marcescens bacteria.
BAXTER HEPARIN RECALL LAWSUITS
The product liability lawyers at Saiontz, Kirk & Miles, P.A. are reviewing potential Heparin recall lawsuits for individuals who have recently experienced a severe reaction after receiving an injection of the blood thinner. To determine if problems experienced by you, a friend or family member may have caused by the recalled batch of Heparin, request a free consultation.
