Blood Safety:

Recalls and Withdrawals of Plasma Products

T-HEHS-98-166: Published: May 7, 1998. Publicly Released: May 7, 1998.

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Bernice Steinhardt
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GAO discussed the amount of plasma products, and in particular the amount of intravenous immune globulin (IVIG), that was being lost due to removal of products from the market, focusing on the: (1) number of recent product recalls and withdrawals; (2) reasons for these actions; (3) different types of plasma products affected; (4) amount of product that has been returned as a result of these actions; and (5) current shortage of IVIG of reducing the number of donors for each plasma product.

GAO noted that: (1) the data showed that only a small proportion of distributed IVIG--about 1.1 percent--has been removed from the market as a result of recalls or withdrawals; (2) however, only 5 percent of the vials of plasma products that were recalled or withdrawn has been retrieved to date; (3) while additional quantities might still be retrieved, some portion of these products has already been transfused or is otherwise unretrievable; (4) further, changes to reduce the number of donors in each product appear unrelated to the current shortages; (5) during the period GAO reviewed, 11 manufacturers reported to the Food and Drug Administration (FDA) that they undertook a total of 12 recalls (affecting 33 lots of 7 types of plasma products) and 38 withdrawals (affecting 1,001 lots of 10 types of products); (6) the reasons for the product recalls varied, but generally they related to specific manufacturing errors resulting in problems in product potency, sterility assurance, or incorrect labeling; (7) the product withdrawals were all related to donors who were diagnosed with Creutzfeldt-Jakob disease (CJD) or were considered to be at increased risk for CJD; (8) as reported to FDA, the proportion of IVIG vials retrieved following a recall was 15 percent, which amounted to less than 1 percent of total IVIG distributed in 1997; (9) in total, about one-third, or 38 percent, of the number of vials of all plasma products recalled has actually been retrieved from distribution or known to be destroyed; (10) the proportion of distributed products retrieved following a withdrawal has been much lower; (11) data from the plasma product manufacturers showed 6 percent of the vials of IVIG that were withdrawn to actually have been recovered, representing 1 percent of the total product distributed in 1997; (12) for other plasma products, the proportion of distributed vials retrieved following a withdrawal was 2 percent; and (13) manufacturers also claim that their production of IVIG was reduced by 5 to 10 percent in 1997 because they had to quarantine or destroy plasma because of CJD risk, but these amounts cannot be verified.

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