The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1021-2017·Announced 2017-08-02

SCA Pharmaceuticals Recalls Epinephrine Bitartrate Injection Due to Sterility Concerns

SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL due to 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 recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric, particularly given the risk of infection from lack of sterility assurance.

Plain-English summary

SCA Pharmaceuticals is recalling Epinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, a prescription-only medication. The recall is being conducted because the product has a lack of assurance of sterility and has the potential to leak.

The affected lots are 20170502@31, 20170508@34, 20170508@70, and 20170512@15. The distribution pattern for this recall is nationwide. The product is manufactured by SCA Pharmaceuticals in Little Rock, Arkansas.

Healthcare providers and patients should stop using the recalled product and contact their healthcare provider for further instructions. Consumers should not use the product if it is leaking or if there are concerns about its sterility.

The recalled product

Product
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
Manufacturer
SCA Pharmaceuticals
Category
Drug — Injection
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 (4)

  • Lots: 20170502@31 BUD: 7/16/2017
  • 20170508@34 BUD: 7/22/2017
  • 20170508@70 BUD: 7/22/2017
  • 20170512@15 BUD: 7/26/2017

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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