PHENYLephrine HCl Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling PHENYLephrine HCl 800 mcg/10 mL injections due to lack of assurance of sterility. The recall affects 3,671 syringes distributed nationwide.
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 product with lack of assurance of sterility. Although no reported illnesses or injuries are documented, injectable drugs without sterility assurance constitute a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
SCA Pharmaceuticals, LLC, has initiated a recall of PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection (80 mcg/mL concentration) due to lack of assurance of sterility. The recall affects 3,671 syringes (with an expanded recall of 1,911 additional syringes) distributed nationwide.
The specific product recalled is a 10 mL fill in 12 mL syringes, Rx only, manufactured by SCA Pharmaceuticals at their facility in Windsor, Connecticut (NDC 70004-0816-12). Five lot numbers are affected: Lot 1223045974 (Exp 12/18/23), Lot 1223046535 (Exp 01/11/24), Lot 1223049152 (Exp 05/02/24), expanded Lot 1223048067 (Exp 04/06/2024), and expanded Lot 1223048792 (Exp 04/17/2024).
Patients and healthcare providers who have received this product should discontinue use and consult with a healthcare provider regarding replacement or alternative treatment. Customers who have dispensed this product should quarantine remaining stock and report any adverse events to SCA Pharmaceuticals and the FDA.
The recalled product
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility-assurance
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 (6)
- Lot #: 1223045974 Exp 12/18/23
- 1223046535 Exp 01/11/24
- 1223049152 Exp 05/02/24 Expanded Lot #: 1223048067
- Exp 04/06/2024
- 1223048792
- Exp 04/17/2024.
Distribution
Distributed nationwide across the United States.
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