Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Reported: March 25, 2020 Initiated: March 5, 2020 #D-1064-2020
Product Description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Reason for Recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 32,592 bags
- Distribution
- Product was distributed throughout the United States.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 32,592 bags.
Why was this product recalled? ▼
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 25, 2020. Severity: Moderate. Recall number: D-1064-2020.
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