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7/23/2001

Companies Recall Albumin Products

Cheryl A. Thompson

Aventis Behring LLC and Baxter Healthcare Corp. last week announced recalls of certain albumin products.

The stoppers used in the production of 129 lots of Albuminar 5, by Aventis Behring, have an anomaly that might compromise the sterility of the albumin solution. As a result, the company is recalling the following lots:

W34209, W34309, W34409, W34509 (expiration date of Sept. 22, 2003),

W34710, W35010, W35110 (Sept. 29, 2003),

W35210, W35310, W35410, W35510, W35610 (Oct. 4, 2003),

W35710, W35810, W35910, W36010, W36110 (Oct. 9, 2003),

W36210, W36310, W36410, W36510, W36610 (Oct. 12, 2003),

W36710, W36810, W37010, W37110 (Oct. 16, 2003),

W37210, W37310, W37410, W37510, W37160 (Oct. 20, 2003),

W37710, W37810, W37910, W38010, W38110 (Oct. 22, 2003),

W38210, W38310, W38410, W38510, W38610 (Oct. 25, 2003),

W38711, W38811, W38911, W39011, W39111 (Oct. 28, 2003),

W39211, W39311, W39411 (Nov. 2, 2003),

W39711, W39811, W39911, W40011, W40111 (Nov. 8, 2003),

W40211, W40311, W40611 (Nov. 11, 2003),

W40811, W41011 (Nov. 15, 2003), 

W41311, W41411, W41411B, W41511, W41611 (Nov. 18, 2003),

W41711, W41811, W41911, W42111 (Nov. 23, 2003),

W42211,W42311, W42411, W42511, W42611 (Nov. 28, 2003),

W42712, W42812, W42912, W43012, W43112 (Nov. 30, 2003),

W43312, W43412, W43512, W43612 (Dec. 3, 2003),

W43712, W43912, W44012 (Dec.5, 2003),

W44212, W44312, W44412, W44612, (Dec. 7, 2003),

W44712, W44812, W44912, W45012, W45112 (Dec. 9, 2003),

W45212, W45312, W45412, W45512 (Dec. 12, 2003),

W45712,W45812, W45912, W46112 (Dec. 16, 2003),

W46412 (Dec. 19, 2003),

X700001, X700201 (Jan. 6, 2004),

X700401 (Jan. 7, 2004),

X700601, X700701 (Jan. 10, 2004),

X701101 (Jan. 18, 2004),

X701501, X701601, X701901 (Jan. 21, 2004),

X702602, X702702 (Jan. 28, 2004),

X704602, X704702, X704902 (Feb. 15, 2004),

X705002, X705202, X705302, X705402 (Feb. 18, 2004),

X707203, X707303 (March 16, 2004),

X707503, X707703 (Mach 21, 2004),

X707803 (March 22, 2004),

X708203, X708403 (March 25, 2004), and

X708604 (March 29, 2004).

After the initial announcement, the company said it was also recalling lot X701001 (expiration date of Jan. 18, 2004).

Aventis Behring said it received one report of an adverse event that might be associated with the administration of one of the above lots of albumin solution.

Baxter is recalling one lot of Buminate 5%—29240641AA (expiration date of Dec. 2, 2002)—because of results from a test not required by the Food and Drug Administration. Polymerase chain reaction assay indicated a low level of human immunodeficiency virus type 2 in a sample of the plasma manufacturing pool from which lot 29240641AA was derived.