Phenylephrine HCl Injectable Recalled Nationwide for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
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 recall is classified as FDA Class II for a sterility assurance failure in an injectable medication. No illnesses or hospitalizations have been reported, and the hazard is potential rather than confirmed, placing this at the High severity level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
SCA Pharmaceuticals is recalling Phenylephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection supplied in 10 mL fill, 12 mL syringes (NDC 70004-0811-12). Approximately 10,017 syringes were distributed nationwide, with an additional 2,579 units added to the recall scope.
The recall was issued due to lack of assurance of sterility. This means the manufacturer was unable to confirm that all units met required sterility standards, which is critical for injectable medications to prevent infection.
Healthcare facilities and providers that received affected lots should stop use immediately. Affected lot numbers include: 1223045040, 1223046397, 1223046505, 1223047254, 1223047436, 1223047938, 1223049150, 1223049300, 1223048569, and 1223049600, with expiration dates ranging from November 2023 through May 2024. Patients who received this product should consult their healthcare provider.
The recalled product
- Product
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- lack-of-sterility
- microbial-contamination
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 #: 1223045040 Exp 11/13/23
- 1223046397 Exp 01/06/24
- 1223046505 Exp 01/10/24
- 1223047254 Exp 02/08/24
- 1223047436 Exp 02/15/24
- 1223047938 Exp 03/13/24
- 1223049150 Exp 05/02/24
- 1223049300 Exp 05/09/24
- Expanded Lot #: 1223048569
- Exp 04/06/2024
- 1223049600
- Exp 05/19/2024
Distribution
Distributed nationwide across the United States.
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