Bulletin

Heparin Injection

21 October 2009

Products Affected - Description

Heparin Sodium for Injection
Heparin sodium injection, Baxter
1,000 unit/mL, 1 mL vial (NDC 00641-0391-21)
1,000 unit/mL, 1 mL vial, package of 25 (NDC 00641-0391-25)
1,000 unit/mL, 10 mL multiple-dose vial (NDC 00641-2440-41)
1,000 unit/mL, 10 mL multiple-dose vials, package of 25 (NDC 00641-2440-45)
1,000 unit/mL, 30 mL multiple-dose vial (NDC 00641-2450-41)
1,000 unit/mL, 30 mL multiple-dose vials package of 25 (NDC 00641-2450-45)
5,000 unit/mL, 1 mL vial (NDC 00641-0400-21)
5,000 unit/mL, 1 mL vial, package of 25 (NDC 00641-0400-25)
5,000 unit/mL, 10 mL multiple-dose vial (NDC 00641-2460-41)
5,000 unit/mL, 10 mL multiple-dose vials, package of 25 (NDC 00641-2460-45)
10,000 unit/mL, 1 mL vial (NDC 00641-0410-21)
10,000 unit/mL, 1 mL vial, package of 25 (NDC 00641-0410-25)
10,000 unit/mL, 4 mL multiple-dose vial (NDC 00641-2470-41)
10,000 unit/mL, 4 mL multiple-dose vials, package of 25 (NDC 00641-2470-45)

Heparin sodium injection, Hospira
5000 unit/mL, 1 mL Carpuject, package of 10 (NDC 00409-1402-31)
10,000 unit/mL, 0.5 mL iSecure Prefilled syringe, package of 10 (NDC 00409-1316-25)
10,000 unit/mL, 0.5 mL Carpuject Luer Lock Slim-Pak, package of 10 (NDC 00409-1316-66)
10,000 units/mL, 0.5 mL Carpuject Luer Lock, package of 50 (NDC 00409-1316-32)

Heparin Sodium Flush Solution
Heparin sodium flush solution for injection, Baxter
10 unit/mL, 1 mL vial (NDC 00641-0392-21)
10 unit/mL, 1 mL vial, package of 25 (NDC 00641-0392-25)
10 unit/mL preservative-free, 1 mL vial, package of 25 (NDC 00641-0272-25)
10 unit/mL, 2 mL vial (NDC 00641-0393-21)
10 unit/mL, 2 mL vial, package of 25 (NDC 00641-0393-25)
10 unit/mL, 10 mL multiple-dose vial, package of 25 (NDC 00641-2438-45)
10 unit/mL, 30 mL multiple-dose vial, package of 25 (NDC 00641-2442-45)
100 unit/mL, 1 mL vial (NDC 00641-0389-21)
100 unit/mL, 1 mL vial, package of 25 (NDC 00641-0389-25)
100 unit/mL preservative-free, 1 mL vial, package of 25 (NDC 00641-0273-25)
100 unit/mL, 2 mL vial (NDC 00641-0387-21)
100 unit/mL, 2 mL vial, package of 25 (NDC 00641-0387-25)
100 unit/mL, 10 mL multiple-dose vial, package of 25 (NDC 00641-2436-45)
100 unit/mL, 30 mL multiple-dose vial, package of 25 (NDC 00641-2443-45)

Reason for the Shortage

Baxter has recalled all single-dose and multiple-dose vials of heparin sodium 1,000 unit/mL, 5,000 unit/mL and 10,000 unit/mL concentrations, as well as all heparin lock flush products (i.e., 10 unit/mL and 100 unit/mL).^1-3 In early 2008, Baxter recalled nine lots of the 1,000 unit/mL concentration and temporarily stopped manufacturing all multiple-dose vials of its 1,000 unit/mL, 5,000 unit/mL, and 10,000 unit/mL heparin sodium injection, due to recent reports of severe allergic reactions in patients receiving bolus doses of these products.^4-9 However, the warning was broadened to include all heparin vial products in all concentrations, as these are obtained from the same source manufacturer. Baxter has stopped manufacturing and shipping these products in order to investigate the cause of these adverse events.^1-3,10
APP was allocating supplies of its heparin sodium in response to the Baxter action.¹¹
Hospira states the shortage is due to supply and demand issues.¹²
B. Braun recalled 23 lots of their heparin sodium large volume infusion solutions as a precautionary measure after their supplier found a heparin-like contaminant in one lot of raw material. Product subject to the recall was distributed in both the US and Canada, including:¹³
- Heparin sodium 1,000 unit/500 mL in 0.9% Sodium Chloride injection (NDC 00264-9872-10): Lot numbers J7C477, J7C557, J7C611, J7C705, J7D485, J7E415, J7E416, J7E589, J7N519, and J7N676.
- Heparin sodium 20,000 unit/500 mL in Dextrose 5% injection (no NDC number, not distributed in US): Lot number J7D580
- Heparin sodium 25,000 unit/250 mL in Dextrose 5% injection (NDC 00264-9587-20): Lot numbers J7C470, J7D490, J7E420 (not distributed in US), J7E494, J7N556, and J7P476.
- Heparin sodium 25,000 unit/500 mL in Dextrose 5% injection (NDC 00264-9577-10): Lot numbers J7C684, J7D496, J7E500, J7E577 (not distributed in US), J7N604, and J7P404.
Covidien recalled 32 lots of prefilled heparin lock syringes after their supplier found a heparin-like contaminant in two lots of raw material. The affected lots include:¹⁴
- Heparin sodium 10 unit/mL, 2.5 mL lock flush syringe, NDC 17474-0123-02 (Lot 7051444)
- Heparin sodium 10 unit/mL, 3 mL lock flush syringe, NDC 17474-0123-03 (Lots 7051524, 7113214)
- Heparin sodium 10 unit/mL, 5 mL lock flush syringe, NDC 17474-0123-05 (Lots 7051524, 7082274, 7113164, 7113174)
- Heparin sodium 10 unit/mL, 5 mL lock flush syringe with Bluntip cannula, NDC 08881-1571-25 (Lot 7082274)
- Heparin sodium 10 unit/mL, 10 mL lock flush syringe, NDC 17474-0123-01 (Lot 7082274, 7113214)
- Heparin sodium 100 unit/mL 3 mL lock flush syringe, NDC 17474-0125-03 (Lots 7041194, 7072154, 7113034, 8010194)
- Heparin sodium 100 unit/mL 5 mL lock flush syringe, NDC 17474-0125-05 (Lots 7041194, 7041204, 7051534, 7051544, 7051554, 7071924, 7072034, 7072044, 7072054, 7072064, 7072154, 7082284, 7102804, 7113034, 7113044, 7113054, 7113104, 7113114, 7113154, 8010064, 8010114, 8010134, 8010174)
- Heparin sodium 100 unit/mL 5 mL lock flush syringe with Bluntip cannula, NDC 08881-5911-25 (Lot 7082284)
- Heparin sodium 100 unit/mL 10 mL lock flush syringe, NDC 17474-0125-01 (Lot 7113064)

Estimated Resupply Dates

Heparin Sodium for Injection

Baxter is not currently shipping any heparin in vials.^2-3,10
APP has supplies of heparin sodium in all presentations available.¹¹
Hospira has their 5000 unit/mL Carpuject syringes and 10,000 unit/mL iSecure and Carpuject syringes on intermittent back order and the company is releasing product as it becomes available. All other presentations of heparin sodium injection are available.¹²

Heparin Sodium Large Volume Infusion Solutions

Baxter's heparin sodium large volume infusion solutions are not affected by this warning.^2-6 Baxter has large volume infusion solutions available in all presentations.¹⁰
Hospira’s large volume infusion solutions are available.¹²
B.Braun's heparin sodium large volume infusion solutions are available.^13,15

Heparin Sodium Flush Solution

Baxter is not currently shipping any heparin in vials.^2-3,10
Heparin sodium flush solutions are made by several manufacturers. The FDA does not anticipate a shortage of these products.²
APP has supplies of heparin sodium flush solution available.¹¹
Hospira's heparin sodium 10 unit/mL flush solution is available.¹²
Covidien has all of their presentations available.¹⁶

Implications for Patient Care

Heparin sodium injection is labeled for anticoagulant therapy including prevention and treatment of venous thrombosis; for prevention of postoperative deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major abdominal or thoracic surgery or patients with other risk factors for thromboembolism; for prevention and treatment of PE; for prevention of embolization during chronic atrial fibrillation; for diagnosis and treatment of acute consumption coagulopathies (e.g., disseminated intravascular coagulation); for prevention of clotting in cardiovascular surgery; for prevention and treatment of peripheral arterial embolism; and as an anticoagulant in blood transfusions, extracorporeal circulation procedures, dialysis procedures, and in laboratory blood samples.¹⁷

Safety

Discontinue use of all Baxter's heparin sodium in vials, recalled lots of B. Braun's heparin sodium large volume infusion solutions, and recalled lots of Covidien's prefilled syringes to minimize risk of adverse reactions, including allergic reactions.
Limit use of heparin sodium 10,000 unit/mL and 20,000 unit/mL to minimize risk of medication errors (i.e., inadvertent use of wrong concentration).

Alternative Agents & Management

Table 1 compares heparin sodium with other available anticoagulant products, and Table 2 addresses alternatives in specific situations. Low molecular weight heparins may be acceptable alternatives to heparin sodium in many situations.^17-19 Prior to beginning anticoagulation therapy, clinicians should obtain a baseline complete blood cell count (CBC) with platelets, activated partial thromboplastin time (aPTT), and renal function studies. Each institution must work closely with prescribers to develop strategies for dealing with this shortage.

Related Shortages

References

U.S. Food and Drug Administration. MedWatch Alert: Heparin Sodium Injection Accessed July 16, 2009.
U.S. Food and Drug Administration. FDA Public Health Update. Recall of Heparin Sodium Injection and Heparin Lock Flush Solution (Baxter). Accessed July 16, 2009.
U.S. Food and Drug Administration. Recall -- Firm Press Release. Baxter to Proceed with Recall of Remaining Heparin Sodium Vial Products. Accessed July 16, 2009.
U.S. Food and Drug Administration. Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reactions. Accessed July 16, 2009.
U.S. Food and Drug Administration. Public Health Advisory: Important warnings and instructions for heparin sodium injection (Baxter). Accessed July 7, 2009.
U.S. Food and Drug Administration. Questions and Answers on Heparin Sodium Injection (Baxter). Accessed July 16, 2009.
U.S. Food and Drug Administration. MedWatch Alert: Heparin Sodium Injection 1000 units/mL 10mL and 30 mL Vials. Accessed July 16, 2009.
Baxter. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ml 10 and 30ml Multi-Dose Vials. Accessed July 16, 2009.
Centers for Disease Control and Prevention. Acute Allergic-Type Reactions Among Patients Undergoing Hemodialysis --- Multiple States, 2007-2008. MMWR. 2008; 57(early release): 1-2. Accessed July 16, 2009.
Baxter Healthcare, Customer Service (personal communications). February 7, 11, 22, 25, and 29, March 12 and 24, April 11 and 30, May 14, June 2, July 10, August 12, October 1, November 17, 2008, January 8 and 15, March 2, May 19, July 16, September 18, and October 20, 2009.
APP, Customer Service (personal communications). February 7, 22, 25, and 29, March 12 and 24, April 11 and 30, May 12, June 2, July 10, August 12, October 1, and November 17, 2008, January 5, March 2, May 20, July 16, September 18, and October 20, 2009.
Hospira, Customer Service (personal communications). February 7, 22, 25, and 29, March 10 and 24, April 11 and 30, May 14, June 2, July 10, August 13, October 2, November 17, 2008; January 8, March 2 and 23, May 20, July 16, August 12, September 15, and October 20, 2009.
B. Braun. B. Braun's supplier recall of heparin API prompts voluntary recall of heparin solutions. Accessed July 16, 2009.
Covidien. Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin. Accessed July 16, 2009.
B. Braun, Customer Service (personal communications). February 7, March 24, April 11, May 14, June 2, July 10, August 12, October 2, and November 17, 2008; and January 8, 2009.
Covidien, Customer Service (personal communication). March 31, June 3, August 13, October 2, 2008; and October 21, 2009.
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Updated

Updated October 21, 2009, by Jane Chandramouli, Pharm.D., Drug Information Specialist. Created September 26, 2001 by Erin R. Fox, Pharm.D., and M. Christina Beckwith, Pharm.D., Drug Information Specialists. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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