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.
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,
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0147-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Nov 29, 2023
- FDA report date
- Dec 13, 2023
- Quantity
- 2616 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- STAQ Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0147-2024, exactly as published.
Show all FDA fields
- City
- Denver
- State
- CO
- Status
- Completed
- Country
- United States
- Event ID
- 93505
- Address
- 14135 E 42nd Ave Ste 50
- 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.
- Postal code
- 80239-5214
- Report date
- Dec 13, 2023
- Product type
- Drugs
- Recall number
- D-0147-2024
- Classification
- Class II
- Recalling firm
- STAQ Pharma, Inc.
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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,
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 29, 2023
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 7, 2023