The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0895-2018·Announced 2018-07-11

SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns

SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a sterile admixture, which poses a significant risk of infection or serious injury.

Plain-English summary

SCA Pharmaceuticals, LLC is conducting a voluntary recall of 492 bags of Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bags. The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the sterile admixtures.

The affected product was distributed throughout the United States. The recall covers specific lots with expiration dates of 6/26/2018. The agency has classified this recall as Class II.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units. Patients should contact their healthcare provider if they have questions regarding the medication they received.

The recalled product

Product
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Manufacturer
SCA Pharmaceuticals, LLC
Category
Drug — Sterile Admixture
Hazard
Affected units
492

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)

  • Lot # 20180328@19
  • 20180328@31
  • 20180328@39
  • 20180328@49
  • 20180328@53
  • 20180328@58
  • 20180323@9
  • 20180327@33
  • Exp 6/26/2018

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by SCA Pharmaceuticals, LLC 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 12 products in this recall →

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