Status
Completed
Drug Enforcement D-0147-2024
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.
Classification
Class II
Report Date
December 13, 2023
Termination Date
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Product Information
- 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,
- Product quantity
- 2616 bags
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- STAQ Pharma, Inc.
- Address
-
14135 E 42nd Ave Ste 50
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0147-2024
- Event ID
- 93505
- Recall initiation date
- November 29, 2023
- Center classification date
- December 7, 2023
- 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.
- More code info
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