fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Reported: December 11, 2019 Initiated: November 12, 2019 #D-0568-2020
Product Description
fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Details
- Recalling Firm
- QuVa Pharma, Inc.
- Distribution
- Nationwide.
- Location
- Sugar Land, TX
Frequently Asked Questions
What product was recalled? ▼
fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76. Recalled by QuVa Pharma, Inc..
Why was this product recalled? ▼
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2019. Severity: Moderate. Recall number: D-0568-2020.
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