PHENYLephrine Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls PHENYLephrine HCl injectable syringes nationwide due to lack of sterility assurance. The recall affects 1,118 syringes across two lot numbers distributed throughout the USA.
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 for a lack of sterility assurance in injectable medication. While no illnesses or injuries have been reported, injectable products without sterile assurance represent a serious risk of harm to patients.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection supplied in pre-filled syringes (NDC 70004-0810-11-K). The product consists of 1,118 syringes across two lot numbers: Lot #1223048431 (expiration 04/05/24) and Lot #1223049023 (expiration 04/25/24).
The recall is due to a lack of assurance of sterility. Injectable medications require strict sterility standards to prevent contamination that could pose serious health risks to patients.
The affected syringes were distributed nationwide throughout the USA to healthcare providers and facilities.
The recalled product
- Product
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID fo
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- sterility-failure
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 (2)
- Lot #: 1223048431 exp 04/05/24
- 1223049023 exp 04/25/24
Distribution
Distributed nationwide across the United States.
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