Recalls / Class II
Class IID-0603-2021
Product
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
- Affected lot / code info
- Lot #: 20NG02095, Exp. Date October 2021
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, N/A, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 48 cases
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-04-28
- FDA classified
- 2021-06-09
- Posted by FDA
- 2021-06-16
- Terminated
- 2021-09-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0603-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.