The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1009-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns

SCA Pharmaceuticals is recalling specific lots of fentanyl citrate injection bags due to a lack of assurance of sterility and potential for leaking.

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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an injectable drug presents a significant risk of serious adverse health consequences, aligning with the Severe criteria for high-risk medical products.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling specific lots of fentanyl (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bags. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.

The affected product is prescription-only and was distributed nationwide. The recall covers nine specific lots with expiration dates ranging from July 31, 2017, to August 4, 2017. The lot numbers are 20170502@18, 20170502@39, 20170502@62, 20170503@22, 20170503@4, 20170503@54, 20170504@10, 20170505@15, and 20170506@23.

Healthcare providers and patients should stop using the affected lots and contact SCA Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injectable
Hazard

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 (9)

  • Lots: 20170502@18 BUD: 7/31/2017
  • 20170502@39 BUD: 7/31/2017
  • 20170502@62 BUD: 7/31/2017
  • 20170503@22 BUD: 8/1/2017
  • 20170503@4 BUD: 8/1/2017
  • 20170503@54 BUD: 8/1/2017
  • 20170504@10 BUD: 8/2/2017
  • 20170505@15 BUD: 8/3/2017
  • 20170506@23 BUD: 8/4/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 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 30 products in this recall →

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