Vancomycin Injectable Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across 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 of a risk-of-harm product—an injectable drug with unassured sterility—where no illnesses or injuries have been reported. The theoretical hazard of contamination in a critical-use injectable medication justifies a High rating.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 368 bags of Vancomycin 1.25 g added to 0.9% Sodium Chloride 250 mL Injection nationwide due to lack of assurance of sterility. The affected product is Lot #1223049049 with expiration date 12/28/23 (NDC 70004-0923-59), distributed nationwide in the USA.
Vancomycin is a critical antibiotic used to treat serious bacterial infections, often in hospital settings where immunocompromised patients receive IV therapy. If the product became contaminated during manufacturing or storage, patients receiving non-sterile injections could experience serious complications including infection, sepsis, or other life-threatening conditions.
No illnesses or injuries related to this recall have been reported to date. Healthcare providers and patients should immediately discontinue use of this lot and contact SCA Pharmaceuticals or their pharmacy for replacement product or further instructions.
The recalled product
- Product
- VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable / Vancomycin
- Hazard
- lack-of-sterility
- 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 (1)
- Lot #: 1223049049 Exp 12/28/23
Distribution
Distributed nationwide across the United States.
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