PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
Reported: August 2, 2017 Initiated: July 14, 2017 #D-1004-2017
Product Description
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
Reason for Recall
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 2 bags
- Distribution
- Nationwide in the USA
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.. Recalled by SCA Pharmaceuticals. Units affected: 2 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 2, 2017. Severity: Moderate. Recall number: D-1004-2017.
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