First paragraph, first sentence of release dated November 20, 2018, the number of lots being recalled should read 164 lots (instead of 163 lots). An additional table has also been added listing the lots being recalled.
LAKE ZURICH, Ill.--(BUSINESS WIRE)-- First paragraph, first sentence of release dated November 20, 2018, the number of lots being recalled should read 164 lots (instead of 163 lots). An additional table has also been added listing the lots being recalled.
The corrected release reads:
FRESENIUS KABI ISSUES VOLUNTARY NATIONWIDE RECALL OF SODIUM CHLORIDE INJECTION, USP, 0.9% DUE TO PRODUCT LABELING INCORRECTLY STATING STOPPERS DO NOT CONTAIN LATEX
Fresenius Kabi USA is voluntarily recalling 164 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.
For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Fresenius Kabi USA has not received any reports of adverse events related to this recall.
Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. It is also indicated for use in flushing of intravenous catheters. The product is packaged as Sodium Chloride Injection, USP 0.9%, 10mL fill in a 10mL vial; Sodium Chloride Injection, USP 0.9% 20mL fill in a 20mL vial; both size vials are packaged in a 25-unit tray. See the tables below for a full list of the affected lots including lot numbers and expiration dates.
Fresenius Kabi USA is notifying its distributors and customers by letter and is arranging for return of the recalled product. If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped, the product involved in this recall.
Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.
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Number |
Date |
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| Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial | 63323-186-10 | 63323-186-01 | 918610 | 6013112 | 11/2018 | |||||
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| Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial | 63323-186-10 |
63323-186-01 |
918610 | 6014260 | 05/2019 | |||||
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| Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial | 63323-186-10 | 63323-186-01 | 918610 | 6015118 | 10/2019 | |||||
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| Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial | 63323-186-10 | 63323-186-01 | 918610 | 6016209 | 02/2020 | |||||
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| Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial | 63323-186-10 | 63323-186-01 | 918610 | 6016879 | 06/2020 | |||||
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Number |
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| Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial | 63323-186-20 | 63323-186-03 | 918620 | 6013062 | 11/2018 | |||||
| 6014162 | 05/2019 | |||||||||
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View source version on businesswire.com: https://www.businesswire.com/news/home/20181120005803/en/
Contacts
Company Contact
Matt Kuhn
847-550-5751
Source: Fresenius Kabi
View this news release online at:
http://www.businesswire.com/news/home/20181120005803/en
