Diltiazem HCl Injection Lacks Sterility Assurance; SCA Pharmaceuticals Recalls
SCA Pharmaceuticals is recalling Diltiazem HCl 125 mg Injectable (381 bags) due to lack of sterility assurance. Patients and healthcare providers should not use affected units from lot #1223049625.
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 where the manufacturer cannot assure sterility of an injectable medication. While no illnesses or injuries have been reported, an injectable drug lacking sterility assurance poses a risk of serious infection; therefore, it meets the rubric criterion for a high-risk product where injury has not yet been reported.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection, 125 mL bags. The affected lot is #1223049625 (expiration date January 24, 2024), distributed nationwide, affecting 381 bags total. The product NDC is 70004-0541-35.
The recall was initiated due to lack of assurance of sterility. The manufacturer cannot confirm that the affected units meet required sterility standards for injectable medications.
Patients and healthcare providers who have received this product should not use units from lot #1223049625. Contact SCA Pharmaceuticals or your healthcare provider for information about obtaining alternative medication.
The recalled product
- Product
- Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- 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 #: 1223049625
- Exp 1/24/24
Distribution
Distributed nationwide across the United States.
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