Agency classClass IIOur severity:Severe FDA (Drugs)·D-1000-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling 130 bags of fentanyl citrate injection due to a lack of assurance of sterility caused by potential leaks in the sodium chloride bags used.

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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which carries a risk of significant injury or infection.

Plain-English summary

SCA Pharmaceuticals is recalling 130 bags of fentanyl (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, 100 mL Single Dose Container bags. The product is identified by NDC 70004-0202-32, Lot 20170707@27, and a best-use-by date of 10/5/2017. The recall was initiated because the product was made with recalled 0.9% sodium chloride bags that have the potential to leak, resulting in a lack of assurance of sterility.

The affected product was distributed nationwide in the USA. This is a prescription-only medication. The source text does not specify specific healthcare facilities or patients affected, nor does it report any illnesses or injuries associated with the use of this product.

Healthcare providers and patients should stop using the affected product and contact SCA Pharmaceuticals at (877) 550-5059 for further instructions or to arrange for a return or replacement.

The recalled product

Product: fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable
Hazard: sterility
contamination
Affected units: 130

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 (2)

Lot: 20170707@27
BUD: 10/5/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · SCA Pharmaceuticals

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