PlainRecalls
ModerateClass IICompleted

FDA Drug recall · Reported December 13, 2023

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,

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…

Recall #
D-0147-2024
Affected scope
2616 bags
Initiated
November 29, 2023
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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Staq Pharma, Inc. recalled ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 m… - a moderate-severity action.

ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 m… was recalled by Staq Pharma, Inc. in December 13, 2023. Reason: STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon …. Check the official notice for the remedy. Verify recall #D-0147-2024 with the FDA Drug before acting.

The recall

Staq Pharma, Inc. issued this moderate-severity FDA Drug recall-STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon ….

Moderate
severity level
Class II
classification
December 13, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0147-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0147-2024) was formally reported on December 13, 2023, with the manufacturer initiating the action on November 29, 2023. It is classified under Moderate severity (Class II), with a current status of Completed. Staq Pharma, Inc. is listed as the recalling firm, operating out of Denver, CO. Federal records list the affected scope as 2616 bags.

The documented reason for this recall is: 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 # 13… Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

2616 bags

Related Recalls

6

5 from same agency

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,

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 Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Completed
Recall number D-0147-2024
Date reported December 13, 2023
Date initiated November 29, 2023
Recalling firm Staq Pharma, Inc.
Firm location Denver, CO
Affected scope 2616 bags
Distribution Nationwide within the United States

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0147-2024) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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,. Recalled by Staq Pharma, Inc.. Units affected: 2616 bags.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Drug on December 13, 2023. Severity: Moderate. Recall number: D-0147-2024.
Where was the recalled product distributed?
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0147-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 13, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.