SCA Pharmaceuticals Recalls ePHEDrine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling ePHEDrine 25 mg/5 mL Injection syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.
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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
SCA Pharmaceuticals is recalling 9,416 syringes of ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe. The recall is due to a lack of assurance of sterility, which may result from a defective syringe cap that creates a non-integral unit.
The affected product was distributed to hospitals nationwide. Specific lot numbers and expiration dates are listed in the recall notice, including lots 1220023022, 1220023023, 1220023029, 1220023030, 1220023117, 1220023145, and 1220023166.
Healthcare facilities should check their inventory for these specific lot numbers and stop using the product if found. Patients who have received this medication should consult their healthcare provider if they have concerns about their treatment.
The recalled product
- Product
- ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 9,416
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 (12)
- Lot # 1220023022
- BUD 1/17/2021
- 1220023023
- 1220023029
- BUD 1/19/2021
- 1220023030
- BUD 1/20/2021
- 1220023117
- BUD 1/25/2021
- 1220023145
- BUD 1/26/2021 & 1220023166
- BUD 1/27/2021.
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.
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