PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.
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, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.
Plain-English summary
PharMEDium Services, LLC is recalling specific lots of Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag. The recall was initiated because of a lack of assurance of sterility resulting from a media fill failure at the manufacturer.
The affected product is identified by NDC# 61553-284-48. The specific lots subject to the recall are 171220061D (Exp. 8/1/2017), 171250023D (Exp. 8/6/2017), 171430008D (Exp. 8/22/2017), 171450015D (Exp. 8/24/2017), and 171510062D (Exp. 8/30/2017). The product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected lots and contact PharMEDium Services, LLC at 800-523-7749 for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 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 2K5284 NDC# 61553-284-48
- Manufacturer
- PharMedium Services, Llc
- Category
- Drug — Injectable
- Hazard
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 (5)
- Lots: 171220061D Exp. 8/1/2017
- 171250023D Exp. 8/6/2017
- 171430008D Exp. 8/22/2017
- 171450015D Exp. 8/24/2017
- 171510062D Exp. 8/30/2017
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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