Agency classClass IIOur severity:Severe FDA (Drugs)·D-0188-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.

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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if administered.

Plain-English summary

SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe. The recall is due to a lack of assurance of sterility and the potential for a defective syringe cap, which may result in a non-integral unit.

The affected product was distributed to hospitals nationwide. The recall includes specific lots with expiration dates in January and February 2021. The agency has classified this recall as Class II.

Healthcare facilities should stop using the affected product and contact SCA Pharmaceuticals for further instructions. Consumers should not use the product if they have it in their possession.

The recalled product

Product: ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
defective-packaging
Affected units: 1,879

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 (5)

Lot # 1220023041
BUD 1/20/2021
1220023188
BUD 1/27/2021 & 1220023397
BUD 2/3/2021.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 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 32 products in this recall →

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