Why it was recalled
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Product description
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Three hospitals in DC, VA, CT
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1189-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 27, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 1384 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SCA Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1189-2018, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 80915
- Address
- 8821 Knoedl Ct
- Code information
- 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
- Postal code
- 72205-4600
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1189-2018
- Classification
- Class I
- Recalling firm
- SCA Pharmaceuticals, Inc.
- Product quantity
- 1384 bags
- Termination date
- Jun 2, 2020
- Reason for recall
- Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Three hospitals in DC, VA, CT
- Recall initiation date
- Aug 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2018