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Class II: temporary or reversible health riskTerminated

QuVa Pharma fentaNYL 500 mcg/250 mL Recall

fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0

QuVa Pharma, Inc. · Sugar Land, TX

Risk level
Class II
Reported by FDA
Dec 11, 2019
Recall ID
D-0546-2020
Check your lot numberHow we source this data

Summary

QuVa Pharma recalled fentaNYL 500 mcg/250 mL starting Nov 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0546-2020 on Dec 11, 2019. Reason: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules. Status: Terminated.

Why it was recalled

Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules

Product description

fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37

Lot numbers, UPCs & expiration codes

Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, , 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, , 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, , 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019,, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019,, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/6/2019, 10031178 Exp. 12/9/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031153 Exp. 12/8/2019, 10031376 Exp. 12/6/2019, 10031236 Exp. 12/10/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031236 Exp. 12/10/2019, 10031237 Exp. 12/10/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031731 Exp. 12/22/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031950 Exp. 12/26/2019, 10031979 Exp. 12/29/2019, 10031980 Exp. 12/30/2019, 10032308 Exp. 12/31/2019, 10032309 Exp. 12/31/2019, 10032415 Exp. 1/2/2020, 10032416 Exp. 1/2/2020, 10032804 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032582 Exp. 1/6/2020, 10032808 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032559 Exp. 1/6/2020, 10032582 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032811 Exp. 1/6/2020, 10032805 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10033008 Exp. 1/15/2020, 10033008 Exp. 1/15/2020, 10032038 Exp. 1/19/2020, 10032038 Exp. 1/19/2020, 10032039 Exp. 1/19/2020, 10033008 Exp. 1/15/2020, 10032039 Exp. 1/19/2020

Where it was sold

Nationwide.

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-0546-2020
Classification
Class II
Status
Terminated
Recall initiated
Nov 12, 2019
FDA report date
Dec 11, 2019
Recall type
Voluntary: Firm initiated
Recalling firm
QuVa Pharma, Inc.

Original FDA data

Every field from FDA enforcement report D-0546-2020, exactly as published.

Show all FDA fields
City
Sugar Land
State
TX
Status
Terminated
Country
United States
Event ID
84263
Address
1075 W Park One Dr Ste 100
Code information
Lots: 10029297 Exp. 11/14/2019 10029199 Exp. 11/17/2019, 10029737 Exp. 11/17/2019, 10029763 Exp. 11/17/2019, 10029785 Exp. 11/18/2019, 10029789 Exp. 11/18/2019, , 10029790 Exp. 11/18/2019, 10029894 Exp. 11/20/2019, 10029950 Exp. 11/21/2019, 10030006 Exp. 11/24/2019, , 10030007 Exp. 11/27/2019, 10030336 Exp. 11/27/2019, , 10030941 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030453 Exp. 11/26/2019, 10030887 Exp. 12/4/2019, 10030990 Exp. 12/4/2019, 10030991 Exp. 12/4/2019,, 10030942 Exp. 12/3/2019, 10030886 Exp. 12/2/2019, 10030909 Exp. 12/2/2019, 10030431 Exp. 11/26/2019, 10030432 Exp. 11/26/2019, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031057 Exp. 12/5/2019, 10030990 Exp. 12/4/2019, 10030886 Exp. 12/2/2019,, 10030454 Exp. 11/26/2019, 10031056 Exp. 12/5/2019, 10031058 Exp. 12/5/2019, 10031087 Exp. 12/6/2019, 10031153 Exp. 12/8/2019, 10031087 Exp. 12/6/2019, 10031088 Exp. 12/6/2019, 10031376 Exp. 12/6/2019, 10031178 Exp. 12/9/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031153 Exp. 12/8/2019, 10031376 Exp. 12/6/2019, 10031236 Exp. 12/10/2019, 10031179 Exp. 12/9/2019, 10031152 Exp. 12/8/2019, 10031236 Exp. 12/10/2019, 10031237 Exp. 12/10/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031731 Exp. 12/22/2019, 10031732 Exp. 12/22/2019, 10031616 Exp. 12/19/2019, 10031617 Exp. 12/22/2019, 10031950 Exp. 12/26/2019, 10031979 Exp. 12/29/2019, 10031980 Exp. 12/30/2019, 10032308 Exp. 12/31/2019, 10032309 Exp. 12/31/2019, 10032415 Exp. 1/2/2020, 10032416 Exp. 1/2/2020, 10032804 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032582 Exp. 1/6/2020, 10032808 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032559 Exp. 1/6/2020, 10032582 Exp. 1/6/2020, 10032809 Exp. 1/6/2020, 10032810 Exp. 1/6/2020, 10032811 Exp. 1/6/2020, 10032805 Exp. 1/5/2020, 10032805 Exp. 1/5/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10032534 Exp. 1/14/2020, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10031951 Exp. 12/26/2019, 10033008 Exp. 1/15/2020, 10033008 Exp. 1/15/2020, 10032038 Exp. 1/19/2020, 10032038 Exp. 1/19/2020, 10032039 Exp. 1/19/2020, 10033008 Exp. 1/15/2020, 10032039 Exp. 1/19/2020
Postal code
77478-2576
Report date
Dec 11, 2019
Product type
Drugs
Recall number
D-0546-2020
Classification
Class II
Recalling firm
QuVa Pharma, Inc.
Termination date
Jun 5, 2020
Reason for recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Voluntary / mandated
Voluntary: Firm initiated
Product description
fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx only, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1160-37
Distribution pattern
Nationwide.
Recall initiation date
Nov 12, 2019
Initial firm notification
Letter
Center classification date
Dec 3, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0546-2020, published Dec 11, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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