Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira is recalling 676,872 containers of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Hospira Inc. is recalling 676,872 containers of 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container. The product is identified by NDC 0409-7983-02 and Lot # 16-031-JT*, with an expiration date of April 1, 2014. The asterisk in the lot number may be followed by 01 or 02.
The recall was initiated because the product has the potential for solution to leak at or near the administrative port of the primary container. This defect creates a lack of assurance of sterility for the affected units.
The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and facilities should stop using the recalled product and contact Hospira for further instructions.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
- Manufacturer
- Hospira Inc.
- Category
- Drug — IV Fluids
- Affected units
- 676,872
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 (3)
- Lot #: 16-031-JT*
- Exp 1APR2014
- Note the * may be followed by 01 or 02
Distribution
Related recalls
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29