The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0976-2017·Announced 2017-07-19

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.

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 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

Distributed in 4 states:

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.

See all 4 products in this recall →

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