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Drug Administration]](https://webarchive.library.unt.edu/eot2008/20081006130020im_/http://www.fda.gov/icon/header.gif){kind=icon}
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PRODUCT: |
Gentamicin Sulfate Injection, USP 40 mg/mL |
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SIZE: |
10x 20 mL Multi Dose Vials |
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NDC: |
0641-2331-43 |
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LOT NO(s): |
039030 (EXP. Date 3/02), 039038 (EXP. Date 3/02), 039032 (EXP. Date 3/02), 128108 (EXP. Date 12/01), 039095 (EXP. Date 3/02), 039097 (EXP. Date 3/02), 049002 (EXP. Date 4/02), 039170 (EXP. Date 3/02), 049007 (EXP. Date 4/02), 039198 (EXP. Date 3/02), 049065 (EXP. Date 4/02), 049067 (EXP. Date 4/02), 049108 (EXP. Date 4/02) |
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DISTRIBUTION : |
April 2, 1999 - June 15, 1999 |
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PRODUCT: |
Gentamicin Sulfate Injection, USP 80 mg/2 mL |
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SIZE: |
25 Vials, 2 mL each |
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NDC: |
0641-0395-25 |
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LOT NO(s): |
039089 (EXP. Date 3/02), 039216 (EXP. Date 3/02), 039128 (EXP. Date 3/02), 049026 (EXP. Date 4/02), 049147 (EXP. Date 4/02), 059061 (EXP. Date 5/02), 059058 (EXP. Date 5/02) |
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DISTRIBUTION: |
May 4, 1999 - June 15, 1999 |
ESI Lederle is voluntarily withdrawing twenty lots of Gentamicin Sulfate Injection, USP packaged in 40 mg/mL and 80 mg/2mL strengths. While these lots fully comply with all product specifications, a higher than expected number of adverse experiences (pyrogenic-like reactions such as fever, chills, or dyspnea) have been reported coincidental with the administration of these lots. Other lot numbers of these products are not subject to this withdrawal.
The Food and Drug Administration has full knowledge of this voluntary market withdrawal.
Any questions regarding this action may be directed to ESI Lederle, attention: Product Quality Department at 1-800-999-9384.
As with all medical products, healthcare professionals are strongly encouraged to report any serious adverse events that are associated with the use of Gentamicin Sulfate to either the manufacturer at 1-800-999-9384 or to the FDA's MedWatch program by phone (1-800-FDA-1088), fax (1-800-FDA-0178), internet (www.fda.gov/medwatch) or mail (using postage-paid form) to MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.
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