fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Reported: April 3, 2024 Initiated: November 9, 2023 #D-0396-2024
Product Description
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 500 bags
- Distribution
- Nationwide in the USA
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230. Recalled by SCA Pharmaceuticals, LLC. Units affected: 500 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2024. Severity: Moderate. Recall number: D-0396-2024.
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