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 raises concerns about sterility.
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 assurance of sterility in an intravenous product, which poses a significant risk of serious injury or death if administered.
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 was initiated because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer. This issue means the product may not be sterile, which is a critical requirement for intravenous medications.
The recall affects Lot 171320001D, dated 8/10/2017. The product was distributed nationwide. Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 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 2K5287 NDC# 61553-287-48
- 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: 171320001D
- 8/10/2017
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.
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