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.
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 2/5 (Moderate).
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
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- 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.
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