CLASS II Drug recall · Reported 13 Dec 2023 · FDA Enforcement Report
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg recalled
Staq Pharma is recalling ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/ (2 mg per mL) Injection, distributed nationwide in the US. The recall was initiated on 29 Nov 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0147-2024
- FDA event ID
- 93505
- Recalling firm
- Staq Pharma, Denver, CO
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 29 Nov 2023
- FDA classified
- 7 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Nov 2023 | Recall initiated by company | |
| 7 Dec 2023 | Classified by FDA | +8 days |
| 13 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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,
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it 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.
Which lots 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.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Staq Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | FentaNYL Citrate PF, 500mcg/ (10mcg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS III | Hydromorphone HCL PF, 10mg/ (0.2mg/mL) in Nacl recalled by STAQ Pharma | Staq Pharma | Other | Nationwide |
| Drug | CLASS III | Ketamine Hydrochloride, 50mg/ (10mg/mL), Injection recalled | Staq Pharma | Other | Nationwide |
| Drug | CLASS I | Morphine Sulfate PF 25 mg/ (1 mg/mL) in NaCl in Single Dose Syringe recalled | Staq Pharma | Labeling Errors | CO, OH, TX |
| Drug | CLASS I | HYDROmorphone HCl PF 10 mg/ (0.2mg/mL) in NaCl recalled by STAQ Pharma | Staq Pharma | Labeling Errors | CO, OH, TX |
Other Ropivacaine Pf recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ropivacaine HCL (PF) 0.2% (2mg/mL) Cassette recalled | Banner Pharmacy Services | Sterility | Nationwide |