ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Reported: June 7, 2017 Initiated: May 18, 2017 #D-0877-2017
Product Description
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 70 bags
- Distribution
- Nationwide in the USA
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32. Recalled by SCA Pharmaceuticals. Units affected: 70 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: Product bags leaking at seam.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2017. Severity: Moderate. Recall number: D-0877-2017.
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