Home / Recalls / STAQ Pharma, Inc. / D-0147-2024

D-0147-2024 Class II

Recalled by STAQ Pharma, Inc. — Denver, CO

Recall Details

Product Type
Drugs
Report Date
December 13, 2023
Initiation Date
November 29, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2616 bags

Product Description

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.

Distribution Pattern

Nationwide within the United States

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.

Other recalls by STAQ Pharma, Inc.

  • D-0023-2026 Class III — Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL (October 9, 2025)
  • D-0024-2026 Class III — Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe (October 9, 2025)
  • D-0025-2026 Class III — FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 m (October 9, 2025)
  • D-0634-2022 Class I — Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syr (February 3, 2022)
  • D-0633-2022 Class I — HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose (February 3, 2022)