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,

FDA recall notice · announced December 13, 2023 · Staq Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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,

Reason for recall

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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot#: 23109472A, Exp. date 03/10/2024; 23109473A, Exp. date 03/11/2024; 23109474A, Exp. date 03/13/2024; 23109491A, Exp. date 03/16/2024; 23109492A, Exp. date 03/19/2024; 23109501A, Exp. date 03/25/2024; 23109520A, Exp. date 04/10/2024; 23109521A, Exp. date 04/13/2024; 23109522A, Exp. date 04/03/2024.
Quantity: 2616 bags
Status: Completed
Products in this recall event:
- 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, (D-0147-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.