Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Reported: July 11, 2018 Initiated: June 14, 2018 #D-0897-2018
Product Description
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Reason for Recall
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 2,869 bags
- Distribution
- Product was distributed throughout the United States.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT. Recalled by SCA Pharmaceuticals, LLC. Units affected: 2,869 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 11, 2018. Severity: Moderate. Recall number: D-0897-2018.
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