ROPivacaine HCl 0.2% PF in Sodium Chloride 1 recall
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,
Why was ROPivacaine HCl 0.2% PF in Sodium Chloride 1 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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,
- Recalling firm
- STAQ Pharma, Inc.
- Quantity
- 2616 bags
- Distribution
- Nationwide within the United States
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (drug)