Agency classClass IIOur severity:Severe FDA (Drugs)·D-0977-2017·Announced 2017-07-19

SCA Pharmaceuticals Recalls Potassium Phosphate IV Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling 660 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 recall is classified as FDA Class II and involves a lack of sterility assurance in an intravenous product, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.

Plain-English summary

SCA Pharmaceuticals is recalling 660 bags of Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+). The recall is being conducted due to a lack of sterility assurance. The product is prescription-only and was distributed in Louisiana, Pennsylvania, New York, and Wisconsin.

The affected lots include 20170509@6, 20170519@35, 20170523@22, 20170525@9, 20170605@49, and 20170605@9. These lots have expiration dates ranging from June 23, 2017, to July 20, 2017. The product is manufactured by SCA Pharmaceuticals in Little Rock, Arkansas.

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 product may cause temporary or medically reversible adverse health consequences.

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 70004-0841-40
Manufacturer: SCA Pharmaceuticals
Category: Drug — IV Solution
Hazard: lack-of-sterility
Affected units: 660

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 (11)

Lot #: 20170509@6
Exp 6/23/2017
20170519@35
Exp 7/3/2017
20170523@22
Exp 7/7/2017
20170525@9
Exp 7/9/2017
20170605@49
Exp 7/20/2017
20170605@9

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 →

Same manufacturer · SCA Pharmaceuticals

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Same hazard · lack of sterility