FDA-Drug2023-12-13Class II
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
STAQ Pharma, Inc.
Hazard
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Sold states
Nationwide within the United States
Affected count
2616 bags
Manufactured in
14135 E 42nd Ave Ste 50, Denver, CO, United States
Products
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0147-2024Don't want to check this manually?
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