Injectable Phenylephrine Recall Due to Sterility Assurance Failure
SCA Pharmaceuticals recalled approximately 8,050 syringes of PHENYLephrine HCl injection nationwide due to lack of assured sterility. Affected lots have expiration dates from November 2023 to June 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: FDA Class II classification indicates a serious hazard, and sterility failures in injectable medications carry inherent high risk of infection; no illnesses have been reported to date.
Plain-English summary
SCA Pharmaceuticals has recalled PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection (NDC 70004-0810-22) in 50 mL syringes. The recall encompasses approximately 5,948 syringes, with an expanded recall adding 2,102 additional syringes, for a total of 8,050 units.
The recall was initiated because the affected lots lack assurance of sterility. Sterility is a critical requirement for injectable medications; non-sterile injections could cause serious infections when administered directly into the bloodstream.
The product was distributed nationwide. Affected lots have expiration dates ranging from November 2023 through June 2024. Healthcare facilities should immediately stop using affected inventory and contact SCA Pharmaceuticals or the FDA with questions. Patients who received injections from recalled lots should consult their healthcare provider.
The recalled product
- Product
- PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Hazard
- sterility-assurance-failure
- injection-safety
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 (20)
- Lot #: 1223045282 Exp 11/24/23
- 1223045370 Exp 11/26/23
- 1223045624 Exp 12/07/23
- 1223045723 Exp 12/10/23
- 1223045732 Exp 12/10/23
- 1223046128 Exp 12/24/23
- 1223046133 Exp 12/24/23
- 1223047112 Exp 02/02/24
- 1223047232 Exp 2/07/24
- 1223047398 Exp 02/15/24
- 1223047456 Exp 02/16/24
- 1223047569 Exp 02/18/24
- 1223047694 Exp 02/24/24
- 1223047780 Exp 03/07/24
- 1223047859 Exp 03/08/24
- 1223048119 Exp 03/20/24
- 1223048183 Exp 03/22/24
- 1223048837 Exp 04/18/24
- 1223048838 Exp 04/18/24
- 1223048982 Exp 04/24/24
Distribution
Distributed nationwide across the United States.
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