The Recall Desk
SevereFDA (Drugs)·D-1189-2018·Announced 2018-09-19

SCA Pharmaceuticals Recalls Furosemide Injection Bags Due to Precipitate

SCA Pharmaceuticals is recalling 1,384 bags of Furosemide injection due to visible precipitate. The product was distributed to three hospitals in DC, VA, and CT.

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 I. Per the rubric, an FDA Class I recall must be scored at least 4 (Severe), as it indicates a reasonable probability of serious adverse health consequences.

Plain-English summary

SCA Pharmaceuticals, Inc. is recalling 1,384 bags of Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection. The recall was initiated following a customer complaint regarding the presence of visible precipitate in the product, which is believed to be the active ingredient furosemide.

The affected product is a 100 mL single-dose container bag, prescription only. The specific lots involved include 20180711@18, 20180712@19, 20180712@21, 20180712@24, 20180713@19, 20180727@21, and 20180803@20, with expiration dates ranging from October 3, 2018, to October 26, 2018.

The product was distributed to three hospitals located in the District of Columbia, Virginia, and Connecticut. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.

The recalled product

Product
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.
Affected units
1,384

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)

  • Lots: 20180711@18
  • BUD: 10/3/2018
  • 20180712@19
  • 20180712@21
  • 20180712@24 BUD: 10/4/2018
  • 20180713@19
  • BUD: 10/5/2018
  • 20180727@21
  • BUD: 10/19/2018
  • 20180803@20
  • BUD: 10/26/2018

Distribution

Distributed in 3 states:

Same manufacturer · SCA Pharmaceuticals, Inc.

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