SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

Administration of a drug product that may contain precipitate has the potential to result in serious adverse events due to dosages that may be lower than intended and could lead to therapeutic failures. Intravenous administration of a product with the precipitate can result in blockage of blood vessels and/or catheter occlusions which could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to permanent lung damage.

SCA Pharmaceuticals has received one (1) customer complaint reporting the presence of precipitate. To date, no adverse events have been reported. Conservatively, the firm is voluntarily recalling seven (7) lots of the same product that are within their Beyond Use Date. These lots are listed in the table below:

Product Name	Product Number	Type of Packaging	Indication	SCA Lot Number	Beyond Use Date	Quantity Shipped	Date(s) Distributed
Furosemide 100 mg in 0.9% Sodium Chloride 100 mL bag	70004-0630-32	100 mL IV bag	Diuretic	20180711@18	10/3/2018	106	7/24/18
				20180712@19	10/4/2018	340	7/24/18
				20180712@21	10/4/2018	341	7/24/18
				20180712@24	10/4/2018	248	7/24/18
				20180713@19	10/5/2018	97	7/26/18 – 7/31/18
				20180727@21	10/19/2018	199	8/09/18
				20180803@20	10/26/2018	53	8/14/18

This injectable product’s indicated use and package type is identified in the table above. The lots associated with this recall were distributed to three hospitals in Connecticut, Virginia and Washington, D.C. The product can be identified by the following label:

SCA Pharmaceuticals is notifying the three customers via telephone, email and US mail and is arranging for return/replacement of all recalled product. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals at the address below:

SCA Pharma
8821 Knoedl Ct.
Little Rock, AR 72205

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059 between the hours of 8:00 AM and 5:00 PM (Central Standard Time), Monday through Friday. Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

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