Pharmaceutical Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 40 mg injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider and not use this product.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical due to lack of assurance of sterility. No illnesses or injuries are reported. The hazard is potential contamination from an unsterilized injectable, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection (250 mL bags) with Lot #1223050005 (expiration January 13, 2024) distributed nationwide. The product NDC number is 70004-0825-40.
The recall is due to lack of assurance of sterility. The manufacturer cannot confirm that the injectable product meets required sterility standards.
Patients and healthcare providers who have received or dispensed this product should contact their healthcare provider immediately. This product should not be used.
The recalled product
- Product
- PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Pharmaceutical Injection
- Hazard
- contamination-risk
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 (1)
- Lot #: 1223050005 Exp 01/13/24
Distribution
Distributed nationwide across the United States.
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