Recalls / Class II
Class IID-0147-2024
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,
- Affected lot / code info
- 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.
Why it was 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.
Recalling firm
- Firm
- STAQ Pharma, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 14135 E 42nd Ave Ste 50, Denver, Colorado 80239-5214
Distribution
- Quantity
- 2616 bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-11-29
- FDA classified
- 2023-12-07
- Posted by FDA
- 2023-12-13
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0147-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.