D-0147-2024 Class II
FDA drug recall D-0147-2024 was initiated by STAQ Pharma, Inc. on November 29, 2023 and is designated Class II. 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 rel… Affected quantity: 2616 bags.
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.