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Class II: temporary or reversible health riskTerminated

QuVa Pharma fentaNYL 400 mcg/200 mL Recall

fentaNYL 400 mcg/200 mL (2 mcg/mL) 0

QuVa Pharma, Inc. · Sugar Land, TX

Risk level
Class II
Reported by FDA
Dec 11, 2019
Recall ID
D-0562-2020
Check your lot numberHow we source this data

Summary

QuVa Pharma recalled fentaNYL 400 mcg/200 mL starting Nov 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0562-2020 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 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37

Lot numbers, UPCs & expiration codes

Lots: 10029343 Exp. 11/15/2019, 10029344 Exp. 11/15/2019, 10029345 Exp. 11/15/2019, 10029895 Exp. 11/20/2019, 10029918 Exp. 11/20/2019, 10029919 Exp. 11/20/2019, 10029895 Exp. 11/20/2019, 10030398 Exp. 11/25/2019, 10030399 Exp. 11/25/2019, 10030400 Exp. 11/25/2019, 10031089 Exp. 12/6/2019, 10031059 Exp. 12/5/2019, 10031060 Exp. 12/5/2019, 10031061 Exp. 12/5/2019, 10031326 Exp. 12/12/2019, 10031327 Exp. 12/12/2019, 10031507 Exp. 12/17/2019, 10031480 Exp. 12/19/2019, 10031618 Exp. 12/19/2019, 10031619 Exp. 12/19/2019, 10031672 Exp. 12/20/2019, 10031618 Exp. 12/19/2019, 10031504 Exp. 12/18/2019, 10031733 Exp. 12/22/2019, 10031734 Exp. 12/22/2019, 10031672 Exp. 12/20/2019, 10031815 Exp. 12/23/2019, 10031505 Exp. 12/18/2019, 10031506 Exp. 12/17/2019, 10031328 Exp. 12/12/2019, 10031816 Exp. 12/23/2019, 10031897 Exp. 12/25/2019, 10031919 Exp. 12/25/2019, 10031847 Exp. 12/24/2019, 10031791 Exp. 12/23/2019, 10031792 Exp. 12/23/2019, 10031793 Exp. 12/23/2019, 10031817 Exp. 12/23/2019, 10032279 Exp. 12/31/2019, 10031847 Exp. 12/24/2019, 10032279 Exp. 12/31/2019, 10032334 Exp. 12/31/2019, 10032368 Exp. 1/1/2020, 10032392 Exp. 1/1/2020, 10032278 Exp. 12/31/2019, 10032251 Exp. 12/30/2019, 10032252 Exp. 12/30/2019, 10032930 Exp. 1/13/2020, 10032850 Exp. 1/12/2020, 10032584 Exp. 1/6/2020, 10032850 Exp. 1/12/2020, 10032900 Exp. 1/13/2020, 10032583 Exp. 1/7/2020, 10032901 Exp. 1/13/2020, 10032931 Exp. 1/16/2020, 10032900 Exp. 1/13/2020

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-0562-2020
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-0562-2020, 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: 10029343 Exp. 11/15/2019, 10029344 Exp. 11/15/2019, 10029345 Exp. 11/15/2019, 10029895 Exp. 11/20/2019, 10029918 Exp. 11/20/2019, 10029919 Exp. 11/20/2019, 10029895 Exp. 11/20/2019, 10030398 Exp. 11/25/2019, 10030399 Exp. 11/25/2019, 10030400 Exp. 11/25/2019, 10031089 Exp. 12/6/2019, 10031059 Exp. 12/5/2019, 10031060 Exp. 12/5/2019, 10031061 Exp. 12/5/2019, 10031326 Exp. 12/12/2019, 10031327 Exp. 12/12/2019, 10031507 Exp. 12/17/2019, 10031480 Exp. 12/19/2019, 10031618 Exp. 12/19/2019, 10031619 Exp. 12/19/2019, 10031672 Exp. 12/20/2019, 10031618 Exp. 12/19/2019, 10031504 Exp. 12/18/2019, 10031733 Exp. 12/22/2019, 10031734 Exp. 12/22/2019, 10031672 Exp. 12/20/2019, 10031815 Exp. 12/23/2019, 10031505 Exp. 12/18/2019, 10031506 Exp. 12/17/2019, 10031328 Exp. 12/12/2019, 10031816 Exp. 12/23/2019, 10031897 Exp. 12/25/2019, 10031919 Exp. 12/25/2019, 10031847 Exp. 12/24/2019, 10031791 Exp. 12/23/2019, 10031792 Exp. 12/23/2019, 10031793 Exp. 12/23/2019, 10031817 Exp. 12/23/2019, 10032279 Exp. 12/31/2019, 10031847 Exp. 12/24/2019, 10032279 Exp. 12/31/2019, 10032334 Exp. 12/31/2019, 10032368 Exp. 1/1/2020, 10032392 Exp. 1/1/2020, 10032278 Exp. 12/31/2019, 10032251 Exp. 12/30/2019, 10032252 Exp. 12/30/2019, 10032930 Exp. 1/13/2020, 10032850 Exp. 1/12/2020, 10032584 Exp. 1/6/2020, 10032850 Exp. 1/12/2020, 10032900 Exp. 1/13/2020, 10032583 Exp. 1/7/2020, 10032901 Exp. 1/13/2020, 10032931 Exp. 1/16/2020, 10032900 Exp. 1/13/2020
Postal code
77478-2576
Report date
Dec 11, 2019
Product type
Drugs
Recall number
D-0562-2020
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 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride , 200 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1207-37
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-0562-2020, 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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