SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 20 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The affected product was distributed in LA, PA, NY, and WI.
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, particularly given the risk of infection associated with a lack of sterility assurance in an intravenous product.
Plain-English summary
SCA Pharmaceuticals is recalling 20 bags of Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+). The product is identified by NDC 70004-0841-32 and Lot # 20170602@29, with an expiration date of 7/17/2017. The recall was initiated due to a lack of sterility assurance.
The affected product was distributed in Louisiana, Pennsylvania, New York, and Wisconsin. This is a prescription-only medication manufactured by SCA Pharmaceuticals in Little Rock, Arkansas.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals or their local FDA office for further instructions.
The recalled product
- Product
- Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 20
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 #: 20170602@29
- Exp 7/17/2017
Distribution
Part of a larger recall action
This product is one of 4 recalled by SCA Pharmaceuticals 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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