SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.
What this means for you
Illness, injury, or structural failure has been reported. 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 under the rubric for drug recalls involving potential sterility issues.
Plain-English summary
SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection. The product is a prescription-only, 10 mL single-dose syringe manufactured by SCA Pharmaceuticals in Windsor, Connecticut.
The recall was initiated due to a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit. The affected lots have expiration dates ranging from January 17, 2021, to February 10, 2021.
The product was distributed to hospitals nationwide. Healthcare facilities should stop using the affected product and contact SCA Pharmaceuticals for further instructions.
The recalled product
- Product
- ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 7,257
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 (16)
- Lot # 1220022996
- BUD 1/21/2021
- 1220023017
- BUD 1/20/2021
- 1220023021
- BUD 1/17/2021
- 1220023033
- BUD 1/19/2021
- 1220023146
- BUD 1/26/2021
- 1220023189
- BUD 1/27/2021 1220023242
- BUD 1/25/2021
- 1220023321
- BUD 2/2/2021
- 1220023357 BUD 2/10/2021
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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