Baxter Recalls 5,184 Bags of 0.9% Sodium Chloride Injection Due to cGMP Deviation
Baxter Healthcare is voluntarily recalling 5,184 bags of 0.9% Sodium Chloride Injection USP 50 mL due to a cGMP deviation. The FDA classified this as a Class II recall.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall involving a cGMP deviation for an intravenous drug. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' warranting a score of 3.
Plain-English summary
Baxter Healthcare Corporation is voluntarily recalling 5,184 bags of 0.9% Sodium Chloride Injection USP 50 mL Viaflex containers. The product is identified by NDC 0338-0049-31, Lot P380063, and an expiration date of 12/2019. The recall was initiated on September 6, 2018, and the product was distributed nationwide.
The reason for the recall is a Current Good Manufacturing Practice (cGMP) deviation. The FDA classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The recall status is currently terminated.
Healthcare providers and consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — IV Fluid
- Affected units
- 5,184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: P380063 Exp. 12/2019
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · SODIUM CHLORIDE
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighFresenius Kabi 500 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · cGMP deviation
See all →- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding Limits
FDA (Drugs) · 2026-07-08
- SevereCinacalcet Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2026-07-08
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06
- ModerateIndomethacin Extended-Release Capsules recalled for cGMP deviations
FDA (Drugs) · 2025-06-11
- SevereLubricant Eye Drops Solution recalled due to sterility assurance concerns
FDA (Drugs) · 2025-05-14