Recalls / Class II
Class IID-1064-2020
Product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
- Affected lot / code info
- Lot #: 19EG02012, 19EG02019, Exp. Date 05/2020; 19DG02050, Exp. Date 04/2020
Why it was recalled
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 920 Winter St Bld 950, Waltham, Massachusetts 02451-1521
Distribution
- Quantity
- 32,592 bags
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2020-03-05
- FDA classified
- 2020-03-26
- Posted by FDA
- 2020-03-25
- Terminated
- 2023-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1064-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.