Sodium Chloride Injection Recall: ICU Medical 0990-7984-23
The recall concerns 0.9% Sodium Chloride Injection, 100 mL, USP, from ICU Medical. The overwrap labeling may indicate Sodium Chloride, but the actual product inside may be Potassium Chloride Injection (10 mEq). About 258,480 bags were distributed nationwide in the United States; Lot 1042188 and expiration date 10/31/2027 apply.
| Brand | Otsuka ICU Medical LLC |
|---|---|
| Product | 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23. |
| Reason | Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq |
| Severity | unknown |
| Units affected | 258480 |
| Distribution | Natinowide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use any product from Lot 1042188 or expiring 10/31/2027.
- Quarantine the affected product and arrange return or disposal according to facility policy.
- Contact your healthcare provider or hospital for guidance and possible replacement.
- If you may have been exposed, inform a healthcare professional and seek medical advice.
How to identify the recalled item
| Lot / date codes | Lot #: 1042188, Exp. Date 10/31/2027 |
|---|---|
| Lot / date codes | Lot #: 1042188, Exp. Date 10/31/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Otsuka ICU Medical LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.