PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that compromised sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a lack of sterility assurance for an intravenous product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection. The product is a prescription-only intravenous solution packaged in 150 mL Intravia bags. The recall is limited to Lot 171520062D, which has a date of 8/31/2017.
The recall was initiated because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer. This process failure means the product may not be sterile, which is a critical requirement for intravenous injections.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the recalled lots and contact PharMEDium Services or their local FDA office for further instructions. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
- Manufacturer
- PharMedium Services, Llc
- Category
- Drug — Intravenous Solution
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 (2)
- Lot: 171520062D
- 8/31/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PharMedium Services, Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · PharMedium Services, Llc
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SeverePharmedium Recalls Dexamethasone Sodium Phosphate Infusions Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- SeverePharmedium Recalls Potassium Chloride Infusions Due to Sterility Concerns
FDA (Drugs) · 2018-02-28
- HighInjection Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- LowPharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error
FDA (Drugs) · 2017-06-21
- LowPharmedium Recalls IV Bags with Incorrect Volume Labeling
FDA (Drugs) · 2017-06-21
- HighIV Potassium Phosphate Solution Recalled Due to Sterility Concerns
FDA (Drugs) · 2023-05-31