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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) BUPivacaine HCl 0

QuVa Pharma, Inc. · Sugar Land, TX

Risk level
Class II
Reported by FDA
Dec 11, 2019
Recall ID
D-0550-2020
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-0550-2020 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) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36

Lot numbers, UPCs & expiration codes

Lots: 1002929 Exp. 11/14/2019, 10029839 Exp. 11/19/2019, 10029840 Exp. 11/19/2019, 10029806 Exp. 11/18/2019, 10029860 Exp. 11/18/2019, 10030370 Exp. 11/25/2019, 10030002 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030003 Exp. 11/24/2019, 10030013 Exp. 11/24/2019, 10030014 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030013 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030538 Exp. 11/28/2019, 10030906 Exp. 11/28/2019, 10030905 Exp. 11/28/2019, 10030429 Exp. 11/26/2019, 10031151 Exp. 12/8/2019, 10031039 Exp. 12/5/2019, 10031282 Exp. 12/11/2019, 10031412 Exp. 12/15/2019, 10031432 Exp. 12/16/2019, 10031460 Exp. 12/16/2019, 10031461 Exp. 12/16/2019, 10031462 Exp. 12/16/2019, 10031567 Exp. 12/18/2019, 10031613 Exp. 12/19/2019, 10031614 Exp. 12/19/2019, 10031567 Exp. 12/18/2019, 10031695 Exp. 12/22/2019, 10031667 Exp. 12/20/2019, 10031788 Exp. 12/23/2019, 10031789 Exp. 12/23/2019, 10031790 Exp. 12/23/2019, 10031812 Exp. 12/23/2019, 10031475 Exp. 12/20/2019, 10031476 Exp. 12/20/2019, 10031641 Exp. 12/20/2019, 10031667 Exp. 12/20/2019, 10031668 Exp. 12/20/2019, 10031566 Exp. 12/18/2019, 10031200 Exp. 12/10/2019, 10032006 Exp. 12/27/2019, 10032007 Exp. 12/27/2019, 10032037 Exp. 12/27/2019, 10032249 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031916 Exp. 12/25/2019, 10031917 Exp. 12/25/2019, 10031843 Exp. 12/24/2019, 10031844 Exp. 12/24/2019, 10031866 Exp. 12/24/2019, 10031867 Exp. 12/24/2019, 10032248 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031811 Exp. 12/25/2019, 10031916 Exp. 12/25/2019, 10031868 Exp. 12/24/2019, 10032306 Exp. 12/31/2019, 10032307 Exp. 12/31/2019, 10032332 Exp. 12/31/2019, 10032364 Exp. 1/1/2020, 10032365 Exp. 1/1/2020, 10032389 Exp. 1/1/2020, 10032390 Exp. 1/2/2020, 10032331 Exp. 12/31/2019 10032556 Exp. 1/6/2020, 10031974 Exp. 12/29/2019, 10032556 Exp.1/6/2020 10032557 Exp. 1/6/2020 10032277 Exp. 12/30/2019, 10031974 Exp. 12/29/2019, 10032612 Exp. 1/7/2020, 10032613 Exp. 1/7/2020, 10032635 Exp. 1/7/2020, 10032636 Exp. 1/7/2020, 10032556 Exp. 1/6/2020, 10032557 Exp. 1/6/2020, 10032849 Exp. 1/12/2020, 10032532 Exp. 1/14/2020, 10033351 Exp. 1/16/2020, 10031040 Exp. 12/5/2019

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-0550-2020
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-0550-2020, 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: 1002929 Exp. 11/14/2019, 10029839 Exp. 11/19/2019, 10029840 Exp. 11/19/2019, 10029806 Exp. 11/18/2019, 10029860 Exp. 11/18/2019, 10030370 Exp. 11/25/2019, 10030002 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030003 Exp. 11/24/2019, 10030013 Exp. 11/24/2019, 10030014 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030013 Exp. 11/24/2019, 10030001 Exp. 11/25/2019, 10030538 Exp. 11/28/2019, 10030906 Exp. 11/28/2019, 10030905 Exp. 11/28/2019, 10030429 Exp. 11/26/2019, 10031151 Exp. 12/8/2019, 10031039 Exp. 12/5/2019, 10031282 Exp. 12/11/2019, 10031412 Exp. 12/15/2019, 10031432 Exp. 12/16/2019, 10031460 Exp. 12/16/2019, 10031461 Exp. 12/16/2019, 10031462 Exp. 12/16/2019, 10031567 Exp. 12/18/2019, 10031613 Exp. 12/19/2019, 10031614 Exp. 12/19/2019, 10031567 Exp. 12/18/2019, 10031695 Exp. 12/22/2019, 10031667 Exp. 12/20/2019, 10031788 Exp. 12/23/2019, 10031789 Exp. 12/23/2019, 10031790 Exp. 12/23/2019, 10031812 Exp. 12/23/2019, 10031475 Exp. 12/20/2019, 10031476 Exp. 12/20/2019, 10031641 Exp. 12/20/2019, 10031667 Exp. 12/20/2019, 10031668 Exp. 12/20/2019, 10031566 Exp. 12/18/2019, 10031200 Exp. 12/10/2019, 10032006 Exp. 12/27/2019, 10032007 Exp. 12/27/2019, 10032037 Exp. 12/27/2019, 10032249 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031916 Exp. 12/25/2019, 10031917 Exp. 12/25/2019, 10031843 Exp. 12/24/2019, 10031844 Exp. 12/24/2019, 10031866 Exp. 12/24/2019, 10031867 Exp. 12/24/2019, 10032248 Exp. 12/30/2019, 10032276 Exp. 12/30/2019, 10031811 Exp. 12/25/2019, 10031916 Exp. 12/25/2019, 10031868 Exp. 12/24/2019, 10032306 Exp. 12/31/2019, 10032307 Exp. 12/31/2019, 10032332 Exp. 12/31/2019, 10032364 Exp. 1/1/2020, 10032365 Exp. 1/1/2020, 10032389 Exp. 1/1/2020, 10032390 Exp. 1/2/2020, 10032331 Exp. 12/31/2019 10032556 Exp. 1/6/2020, 10031974 Exp. 12/29/2019, 10032556 Exp.1/6/2020 10032557 Exp. 1/6/2020 10032277 Exp. 12/30/2019, 10031974 Exp. 12/29/2019, 10032612 Exp. 1/7/2020, 10032613 Exp. 1/7/2020, 10032635 Exp. 1/7/2020, 10032636 Exp. 1/7/2020, 10032556 Exp. 1/6/2020, 10032557 Exp. 1/6/2020, 10032849 Exp. 1/12/2020, 10032532 Exp. 1/14/2020, 10033351 Exp. 1/16/2020, 10031040 Exp. 12/5/2019
Postal code
77478-2576
Report date
Dec 11, 2019
Product type
Drugs
Recall number
D-0550-2020
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) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
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-0550-2020, 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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