Medications & Supplements/Prescription Drugs

QuVa Pharma, Inc.: R.E.C.K. Compounded Syringes Recalled for Particulate Matter Contamination

Agency Publication Date: June 22, 2020

Summary

QuVa Pharma, Inc. is recalling 17,050 syringes of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution. This recall was initiated because the Ketorolac vials used to compound the medication, manufactured by Fresenius Kabi, were found to contain particulate matter. While no specific injuries have been reported for this compounding lot, the presence of foreign particles in an injectable medication can lead to serious health complications including inflammation, granulomas, or embolism. These products were distributed nationwide in the US and were compounded at the QuVa facility in Bloomsbury, New Jersey.

Risk

The injection of a solution containing particulate matter can cause local irritation or swelling in response to the foreign material. If the particles reach the bloodstream, they can travel to the lungs or other organs, potentially causing serious blockages (embolism) or long-term inflammatory issues.

What You Should Do

Locate your R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 mL syringes and check the label for NDC 70092143350.
Verify if your product matches one of the affected lot numbers: 30008721, 30008198, 30008554, 30008861, 30008859, 30008949, 30009073, 30009074, 30009138, 30009139, 30009227, 30009228, 30009387, 30009388, 30009410, 30009411, 30009413, 30009412, 30009489, 30009539, or 30009563.
If you have an affected syringe, stop using it immediately and do not administer it to patients.
Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report the possession of recalled medication.
Return any unused syringes to the place of purchase or contact QuVa Pharma, Inc. at 1075 W Park One Dr Ste 100, Sugar Land, Texas, for instructions on how to return the product and obtain a refund.
For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund and medical guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution (50 mL in 60 mL Syringe)

Model:

NDC 70092143350

Recall #: D-1335-2020

Lot Numbers:

30008721 (Exp. 4/26/2020)

30008198 (Exp. 4/29/2020)

30008554 (Exp. 4/29/2020)

30008861 (Exp. 4/30/2020)

30008859 (Exp. 5/5/2020)

30008949 (Exp. 5/10/2020)

30009073 (Exp. 5/14/2020)

30009074 (Exp. 5/17/2020)

30009138 (Exp. 5/17/2020)

30009139 (Exp. 5/19/2020)

30009227 (Exp. 5/19/2020)

30009228 (Exp. 5/20/2020)

30009387 (Exp. 5/27/2020)

30009388 (Exp. 5/27/2020)

30009410 (Exp. 5/28/2020)

30009411 (Exp. 5/28/2020)

30009413 (Exp. 5/31/2020)

30009412 (Exp. 6/1/2020)

30009489 (Exp. 6/1/2020)

30009539 (Exp. 6/3/2020)

30009563 (Exp. 6/3/2020)

Date Ranges: April 2020 - June 2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85547

Status: Resolved

Manufacturer: QuVa Pharma, Inc.

Sold By: Hospitals; Surgical Centers; Healthcare Providers

Manufactured In: United States

Units Affected: 17,050 syringes

Distributed To: Nationwide

Agency Last Updated: June 23, 2020

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Locate your R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 mL syringes and check the label for NDC 70092143350.

Verify if your product matches one of the affected lot numbers: 30008721, 30008198, 30008554, 30008861, 30008859, 30008949, 30009073, 30009074, 30009138, 30009139, 30009227, 30009228, 30009387, 30009388, 30009410, 30009411, 30009413, 30009412, 30009489, 30009539, or 30009563.

If you have an affected syringe, stop using it immediately and do not administer it to patients.

Contact your healthcare provider or pharmacist immediately for guidance on alternative treatments and to report the possession of recalled medication.

Return any unused syringes to the place of purchase or contact QuVa Pharma, Inc. at 1075 W Park One Dr Ste 100, Sugar Land, Texas, for instructions on how to return the product and obtain a refund.

For additional questions or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution (50 mL in 60 mL Syringe)

Model:

NDC 70092143350

Recall #: D-1335-2020

Lot Numbers:

30008721 (Exp. 4/26/2020)

30008198 (Exp. 4/29/2020)

30008554 (Exp. 4/29/2020)

30008861 (Exp. 4/30/2020)

30008859 (Exp. 5/5/2020)

30008949 (Exp. 5/10/2020)

30009073 (Exp. 5/14/2020)

30009074 (Exp. 5/17/2020)

30009138 (Exp. 5/17/2020)

30009139 (Exp. 5/19/2020)

30009227 (Exp. 5/19/2020)

30009228 (Exp. 5/20/2020)

30009387 (Exp. 5/27/2020)

30009388 (Exp. 5/27/2020)

30009410 (Exp. 5/28/2020)

30009411 (Exp. 5/28/2020)

30009413 (Exp. 5/31/2020)

30009412 (Exp. 6/1/2020)

30009489 (Exp. 6/1/2020)

30009539 (Exp. 6/3/2020)

30009563 (Exp. 6/3/2020)

Date Ranges: April 2020 - June 2020