The Recall Desk
ModerateFDA (Drugs)·D-0156-2018·Announced 2018-01-17

SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Missing Labeling

SCA Pharmaceuticals is recalling 1,248 syringes of Ephedrine sulfate 5 mg/mL because the product labels were missing the lot number and beyond-use date.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (missing lot and expiration dates) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

SCA Pharmaceuticals is recalling 1,248 syringes of Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride. The product is distributed in 10 mL single-dose syringes and is available by prescription only. The specific lot number is 20171013@30, with an expiration date of 12/27/2017.

The recall was initiated because the product labels were missing the lot number and the beyond-use date. This labeling error prevents proper identification and tracking of the specific product units.

The affected product was distributed nationwide in the United States. Healthcare providers and patients should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions.

The recalled product

Product
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12
Affected units
1,248

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#: 20171013@30
  • Exp 12/27/2017

Distribution

Distributed nationwide across the United States.