The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0873-2017·Announced 2017-06-07

SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.

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 the source text indicates a lack of assurance of sterility for an injectable product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant harm).

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 370 bags of fentaNYL (as citrate) in 0.9% Sodium Chloride injectable, 10 mcg per mL, 100 mL single-dose containers. The product is identified by NDC 70004-0202-32, Lot # 20170506@14, and has a use-by date of 08/04/17.

The recall was initiated due to a lack of assurance of sterility, specifically because the product bags were found to be leaking at the seam. This defect poses a risk of contamination to the injectable solution.

The affected product was distributed nationwide in the USA. Healthcare providers and patients should stop using the recalled product and contact SCA Pharmaceuticals for further instructions or replacement.

The recalled product

Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable
Hazard
Affected units
370

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 # 20170506@14
  • Use By: 08/04/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

Related recalls

Same manufacturer · SCA Pharmaceuticals

See all →

Same hazard · sterility

See all →

Similar recalls