D-0603-2021 Class II Terminated
FDA drug recall D-0603-2021 was initiated by Fresenius Medical Care Holdings, Inc. on April 28, 2021 and is designated Class II. Reason for recall: Temperature Abuse: Product exposed to temperature outside specified limits. The recall status is terminated (terminated September 17, 2021). Affected quantity: 48 cases.
Recall Details
- Product Type
- Drugs
- Report Date
- June 16, 2021
- Initiation Date
- April 28, 2021
- Termination Date
- September 17, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 cases
Product Description
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Reason for Recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 20NG02095, Exp. Date October 2021