ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
FDA recall notice · announced June 7, 2017 · Sca Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
Reason for recall
Lack of assurance of sterility: Product bags leaking at seam.
Notes
Distribution: Nationwide in the USA
Lot/code information: LOT # 20170510@12, Use By: 06-24-17
Quantity: 240 bags
Status: Terminated
Products in this recall event:
- HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmace (D-0875-2017)
- morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, (D-0871-2017)
- fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceu (D-0873-2017)
- MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharm (D-0878-2017)
- fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceu (D-0872-2017)
- morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, S (D-0870-2017)
- 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. Littl (D-0877-2017)
- PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Ph (D-0879-2017)
- fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Kn (D-0874-2017)
- ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Littl (D-0876-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.