Drug product
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
D-0603-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 cases
- Official record key
drug-enforcement:D-0603-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: Lot #: 20NG02095, Exp. Date October 2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.