Recalls / Class II
Class IID-0827-2018
Product
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
- Affected lot / code info
- Lot # 17LU05005; Exp. 09/18 Part Number 060-10109
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 25,356 1 liter bags
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2017-11-13
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-30
- Terminated
- 2018-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0827-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.