SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 221 bags of Potassium Phosphate IV solution due to a lack of sterility assurance. The 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an IV product warrants a 'Severe' rating (Score 4), as it poses a risk of adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is recalling 221 bags of Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only. The recall is being conducted due to a lack of sterility assurance in the product.
The affected product is identified by NDC 70004-0840-40. Specific lot numbers and expiration dates include: 20170509@2 (Exp 6/23/2017), 20170524@22 (Exp 7/8/2017), 20170602@10 (Exp 7/17/2017), and 20170609@27 (Exp 7/24/2017). The product was distributed in Louisiana, Pennsylvania, New York, and Wisconsin.
Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 221
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 (8)
- Lot #: 20170509@2
- Exp 6/23/2017
- 20170524@22
- Exp 7/8/2017
- 20170602@10
- Exp 7/17/2017
- 20170609@27
- Exp 7/24/2017
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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