来源:osha.gov | 收据日期:2020-11-19
Cross Contamination
已更新:
来源:osha.gov | 收据日期:2020-11-19
Fresenius Kabi USA Dexmedetomidine HCL 在 0.9% 氯化钠注射液中-由于与利多卡因交叉污染而召回, USA
3年前 •source www.fda.gov
Recall notice
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl …
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.
- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020
Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.
Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.
Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Check the full recall details on www.fda.gov
Source: FDA
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