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Class II: temporary or reversible health riskTerminated

QuVa Pharma fentaNYL 200 mcg/100 mL Recall

fentaNYL 200 mcg/100 mL (2 mcg/mL) 0

QuVa Pharma, Inc. · Sugar Land, TX

Risk level
Class II
Reported by FDA
Dec 11, 2019
Recall ID
D-0557-2020
Check your lot numberHow we source this data

Summary

QuVa Pharma recalled fentaNYL 200 mcg/100 mL starting Nov 12, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0557-2020 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 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75

Lot numbers, UPCs & expiration codes

Lots: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020

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-0557-2020
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-0557-2020, 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: 10029306 Exp. 11/14/2019, 10029881 Exp. 11/18/2019, 10029748 Exp. 11/17/2019, 10029881 Exp. 11/18/2019, 10029882 Exp. 11/18/2019, 10029854 Exp. 11/19/2019, 10029882 Exp. 11/18/2019, 10030947 Exp. 12/3/2019, 10030894 Exp. 12/2/2019, 10030442 Exp. 11/26/2019, 10031295 Exp. 12/11/2019, 10031319 Exp. 12/11/2019, 10031518 Exp. 12/17/2019, 10031553 Exp. 12/17/2019, 10031468 Exp. 12/16/2019, 10032703 Exp. 1/8/2020, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031882 Exp. 12/24/2019, 10031802 Exp. 12/23/2019, 10032594 Exp. 1/6/2020, 10032543 Exp. 1/5/2020, 10031906 Exp. 12/25/2019, 10031802 Exp. 12/23/2019, 10031775 Exp. 12/22/2019, 10031582 Exp. 12/18/2019, 10032673 Exp. 1/8/2020, 10032021 Exp. 12/27/2019, 10031582 Exp. 12/18/2019, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10031906 Exp. 12/25/2019, 10031582 Exp. 12/18/2019, 10032405 Exp. 1/1/2020, 10032021 Exp. 12/27/2019, 10031960 Exp. 12/26/2019, 10032380 Exp. 1/1/2020, 10032673 Exp. 1/8/2020
Postal code
77478-2576
Report date
Dec 11, 2019
Product type
Drugs
Recall number
D-0557-2020
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 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
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-0557-2020, 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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