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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84263

27 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 12, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
QuVa Pharma, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

27 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 27

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

D-0546-2020
Recall number
D-0546-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Nationwide.

drug · product 2 of 27

fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.25 mg/mL) in 0.9% Sodium Chloride 250 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1105-37

D-0547-2020
Recall number
D-0547-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029289 Exp. 11/14/2019 10029841 Exp. 11/19/2019, 10029861 Exp. 11/19/2019, 10029863 Exp. 11/19/2019, 10030008 Exp. 11/24/2019, 10029946 Exp. 11/21/2019, 10030009 Exp. 11/24/2019, 10030010 Exp. 11/24/2019, 10030483 Exp. 11/27/2019, 10030482 Exp. 11/27/2019, , 10030958 Exp. 12/3/2019, , 10030908 Exp. 12/2/2019, 10030430 Exp. 11/26/2019, 10030989 Exp. 12/4/2019, 10030959 Exp. 12/3/2019, 10030907 Exp. 12/2/2019, 10030908 Exp. 12/2/2019, 10031283 Exp. 12/11/2019, 10031345 Exp. 12/12/2019, 10031346 Exp. 12/12/2019, 10031477 Exp. 12/16/2019, 10031433 Exp. 12/15/2019, 10031434 Exp. 12/15/2019, 10031478 Exp. 12/16/2019, 10031568 Exp. 12/18/2019, 10031615 Exp. 12/19/2019, 10031479 Exp. 12/18/2019, 10031568 Exp. 12/18/2019, 10031569 Exp. 12/18/2019, 10031570 Exp. 12/18/2019, 10031642 Exp. 12/20/2019, 10031591 Exp. 12/19/2019, 10031813 Exp. 12/23/2019, 10031814 Exp. 12/23/2019, 10032008 Exp. 12/27/2019, 10032009 Exp. 12/27/2019, 10031759 Exp. 12/26/2019, 10031946 Exp. 12/26/2019, 10031846 Exp. 12/24/2019, 10032250 Exp. 12/30/2019, 10031845 Exp. 12/24/2019, 10031846 Exp. 12/24/2019, 10032366 Exp. 1/1/2020, 10032391 Exp. 1/1/2020, , 10032333 Exp. 12/31/2019, 10032445 Exp. 1/2/2020, 10031760 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031975 Exp. 12/29/2019, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10031760 Exp. 1/7/2020, 10032533 Exp. 1/7/2020, 10031976 Exp. 12/29/2019, 10031977 Exp. 12/29/2019, 10032664 Exp. 1/8/2020, 10032665 Exp. 1/8/2020, 10032533 Exp. 1/7/2020, , 10032614 Exp. 1/7/2020, 10032615 Exp. 1/7/2020

Distribution pattern

Nationwide.

drug · product 3 of 27

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75

D-0548-2020
Recall number
D-0548-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10029829 Exp. 11/18/2019, 10029883 Exp. 11/19/2019, 10030056 Exp. 11/24/2019, 10029883 Exp. 11/19/2019, 10030867 Exp. 11/27/2019, 10030056 Exp. 11/24/2019, 10031005 Exp. 12/4/2019, 10030950 Exp. 12/3/2019, 10031005 Exp. 12/4/2019, 10031103 Exp. 12/6/2019, 10031006 Exp. 12/4/2019, 10031142 Exp. 12/8/2019, 10031274 Exp. 12/10/2019, 10031710 Exp. 12/12/2019, 10031628 Exp. 12/19/2019, 10031777 Exp. 12/22/2019, 10031683 Exp. 12/22/2019, 10032050 Exp. 12/29/2019, 10032051 Exp. 12/29/2019, 10032435 Exp. 1/2/2020, 10032468 Exp. 1/2/2020, 10032545 Exp. 1/5/2020, 10032676 Exp. 1/8/2020, 10032677 Exp. 1/8/2020, 10032595 Exp. 1/6/2020, 10032545 Exp. 1/5/2020, 10032596 Exp. 1/6/2020

Distribution pattern

Nationwide.

drug · product 4 of 27

fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (0.625 mg/mL) in 0.9% Sodium Chloride in 250 mL Bag, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1269-37

D-0549-2020
Recall number
D-0549-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029288 Exp. 11/14/2019, 10029762 Exp. 11/14/2019, 10029788 Exp. 11/18/2019, 10029838 Exp. 11/19/2019, 10029948 Exp. 11/21/2019, 10029949 Exp. 11/21/2019, 10030337 Exp. 11/24/2019, 10029838 Exp. 11/19/2019, 10030539 Exp. 11/28/2019, 10030943 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030963 Exp. 12/3/2019, 10030964 Exp. 12/3/2019, 10030888 Exp. 12/2/2019, 10030963 Exp. 12/3/2019, 10031129 Exp. 12/8/2019, 10031284 Exp. 12/11/2019, 10031414 Exp. 12/15/2019, 10031435 Exp. 12/16/2019, 10031735 Exp. 12/22/2019, 10032253 Exp. 12/30/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10032280 Exp. 12/31/2019, 10030455 Exp. 11/26/2019, 10032535 Exp. 1/6/2020, 10033009 Exp. 1/15/2020, 10032585 Exp. 1/14/2020, 10033009 Exp. 1/15/2020

Distribution pattern

Nationwide.

drug · product 5 of 27

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

D-0550-2020
Recall number
D-0550-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Nationwide.

drug · product 6 of 27

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1099-49

D-0551-2020
Recall number
D-0551-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029934 Exp. 11/19/2019, 10029820 Exp. 11/18/2019, 10029872 Exp. 11/19/2019, 10029873 Exp. 11/19/2019, 10030868 Exp. 11/28/2019, 10030567 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10030567 Exp. 11/28/2019, 10030568 Exp. 11/28/2019, 10030892 Exp. 12/2/2019, 10031210 Exp. 12/9/2019, 10031211 Exp. 12/9/2019, 10031209 Exp. 12/12/2019, 10031439 Exp. 12/15/2019, 10031700 Exp. 12/22/2019, 10031438 Exp. 12/15/2019, 10031766 Exp. 12/26/2019, 10032225 Exp.12/29/2019, 10032260 Exp. 12/30/2019, 10032343 Exp. 12/31/2019,

Distribution pattern

Nationwide.

drug · product 7 of 27

fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/mL) in 0.9% Sodium Chloride 250 mL Bag Rx, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1225-37

D-0552-2020
Recall number
D-0552-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029346 Exp. 11/15/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10029347 Exp. 11/15/2019, 10029982 Exp. 11/22/2019, 10030017 Exp. 11/24/2019, 10029982 11/22/2019, 10030017 Exp. 11/24/2019, 10030401 Exp. 11/25/2019, 10030017 Exp. 11/24/2019, 10031092 Exp. 12/6/2019, 10030401 Exp. 11/25/2019, 10031092 12/6/2019, 10031349 Exp. 12/12/2019, 10032011 Exp. 12/27/2019, 10032012 Exp. 12/27/2019, 10032505 Exp. 1/5/2020, 10032447 Exp. 1/2/2020, 10032932 Exp. 1/13/2020,

Distribution pattern

Nationwide.

drug · product 8 of 27

fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37

D-0553-2020
Recall number
D-0553-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029202 Exp. 11/17/2019, 10029753 Exp. 11/17/2019, 10029756 Exp. 11/17/2019, 10029792 Exp. 11/18/2019, 10029793 Exp. 11/18/2019, 10029808 Exp. 11/18/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029757 Exp. 11/17/2019, 10029758 Exp. 11/17/2019, 10029809 Exp. 11/18/2019, 10029810 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10029897 Exp. 11/20/2019, 10029793 Exp. 11/18/2019, 10029920 Exp. 11/19/2019, 10030394 Exp. 11/25/2019, 10030395 Exp. 11/25/2019, 10030479 Exp. 11/27/2019, 10030480 Exp. 11/27/2019, 10030481 Exp. 11/27/2019, 10030449 Exp. 11/26/2019, 10030450 Exp. 11/26/2019, 10030451 Exp. 11/26/2019, 10030883 Exp. 12/2/2019, 10030885 Exp. 12/2/2019, 10030507 Exp. 11/27/2019, 10030508 Exp. 11/27/2019, 10030936 Exp. 12/3/2019, 10030937 Exp. 12/3/2019, 10030956 Exp. 12/3/2019, 10030903 Exp. 11/30/2019, 10030904 Exp. 11/30/2019, 10030988 Exp. 12/4/2019, 10030938 Exp. 12/3/2019, 10030955 Exp. 12/3/2019, 10030884 Exp. 11/30/2019, 10030902 Exp. 11/30/2019, 10030986 Exp. 12/4/2019, 10030987 Exp. 12/4/2019, 10031009 Exp. 12/4/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031150 Exp. 12/8/2019, 10031009 Exp. 12/4/2019, 10030506 Exp. 11/27/2019, 10030448 Exp. 11/26/2019, 10031176 Exp. 12/9/2019, 10031385 Exp. 12/9/2019, 10031127 Exp. 12/8/2019, 10031128 Exp. 12/8/2019, 10031149 Exp. 12/8/2019, 10031234 Exp. 12/10/2019, 10031235 Exp. 12/10/2019, 10031259 Exp. 12/10/2019, 10031261 Exp. 12/10/2019, 10031177 Exp. 12/9/2019, 10031384 Exp. 12/9/2019, 10030426 Exp. 11/26/2019, 10030427 Exp. 11/26/2019, 10031260 Exp. 12/10/2019, 10030957 Exp. 12/3/2019, 10031389 Exp. 12/11/2019, 10030957 Exp. 12/3/2019, 10030904 Exp. 11/30/2019, 10031502 Exp. 12/17/2019, 10031474 Exp. 12/16/2019, 10031503 Exp. 12/17/2019, 10031589 Exp. 12/19/2019, 10031611 Exp. 12/19/2019, 10031565 Exp. 12/18/2019, 10031502 Exp. 12/17/2019, 10031563 Exp. 12/17/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031730 Exp. 12/22/2019, 10031588 Exp. 12/19/2019, 10031589 Exp. 12/19/2019, 10031610 Exp. 12/19/2019, 10031564 Exp. 12/18/2019, 10031565 Exp. 12/18/2019, 10031785 Exp. 12/23/2019, 10031693 Exp. 12/22/2019, 10031694 Exp. 12/22/2019, 10031729 Exp. 12/22/2019, 10031640 Exp. 12/20/2019, 10031564 Exp. 12/18/2019, 10031786 Exp. 12/23/2019, 10031810 Exp. 12/23/2019, 10031893 Exp. 12/25/2019, 10031894 Exp. 12/25/2019, 10032247 Exp. 12/30/2019, 10032218 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031915 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031864 Exp. 12/24/2019, 10032217 Exp. 12/29/2019, 10031914 Exp. 12/25/2019, 10031841 Exp. 12/24/2019, 10031842 Exp. 12/24/2019, 10032362 Exp. 1/1/2020, 10032363 Exp. 1/1/2020, 10032387 Exp. 1/1/2020, 10032304 Exp. 12/31/2019, 10032388 Exp. 1/1/2020, 10032554 Exp. 1/6/2020, 10032503 Exp. 1/5/2020, 10032504 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032580 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020, 10032554 Exp. 1/6/2020, 10032555 Exp. 1/6/2020, 10032581 Exp. 1/6/2020, 10032504 Exp. 1/5/2020, 10032529 Exp. 1/5/2020, 10032530 Exp. 1/5/2020

Distribution pattern

Nationwide.

drug · product 9 of 27

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/mL) in 0.9% Sodium Chloride 200 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1440-76

D-0554-2020
Recall number
D-0554-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029307 Exp. 11/14/2019, 10029939 Exp. 11/20/2019, 10029884 Exp. 11/19/2019, 10029915 Exp. 11/20/2019, 10030385 Exp. 11/25/2019, 10030386 Exp. 11/25/2019, 10030923 Exp. 12/11/2019, 10031320 Exp. 12/11/2019, 10031025 Exp. 12/12/2019, 10031024 Exp. 12/12/2019, 10032678 Exp. 1/8/2020, 10032993 Exp. 1/14/2020

Distribution pattern

Nationwide.

drug · product 10 of 27

fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36

D-0555-2020
Recall number
D-0555-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029286 Exp. 11/14/2019 10029287 Exp. 11/14/2019 10029761 Exp. 11/14/2019 10029764 Exp. 11/14/2019 10029754 Exp. 11/17/2019 10029787 Exp. 11/17/2019 10029862 Exp. 11/18/2019 10029892 Exp. 11/20/2019 10029893 Exp. 11/20/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10029947 Exp. 11/21/2019 10029951 Exp. 11/21/2019 10030011 Exp. 11/24/2019 10030012 Exp. 11/24/2019 10030018 Exp. 11/24/2019 10030346 Exp. 11/24/2019 10030345 Exp. 11/24/2019 10030880 Exp. 12/2/2019 10030882 Exp. 12/2/2019 10030983 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10030933 Exp. 12/3/2019 10030934 Exp. 12/3/2019 10030935 Exp. 12/3/2019 10030881 Exp. 12/2/2019 10030982 Exp. 12/4/2019 10030983 Exp. 12/4/2019 10030984 Exp. 12/4/2019 10030985 Exp. 12/4/2019 10031035 Exp. 12/5/2019 10031036 Exp. 12/5/2019 10031037 Exp. 12/5/2019 10031038 Exp. 12/5/2019 10031175 Exp. 12/9/2019 10031198 Exp. 12/10/2019 10031199 Exp. 12/10/2019 10031232 Exp. 12/10/2019 10031242 Exp. 12/10/2019 10031386 Exp. 12/10/2019 10031174 Exp. 12/9/2019 10030424 Exp. 11/26/2019 10030425 Exp. 11/26/2019 10031233 Exp. 12/10/2019 10031459 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031410 Exp. 12/15/2019 10031431 Exp. 12/15/2019 10031458 Exp. 12/16/2019 10031459 Exp. 12/16/2019 10031525 Exp. 12/16/2019 10031526 Exp. 12/16/2019 10031608 Exp. 12/19/2019 10031664 Exp. 12/20/2019 10031608 Exp. 12/19/2019 10031609 Exp. 12/19/2019 10031663 Exp. 12/20/2019 10031411 Exp. 12/15/2019 10031840 Exp. 12/24/2019 10031863 Exp. 12/24/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032002 Exp. 12/27/2019 10032003 Exp. 12/27/2019 10032005 Exp. 12/27/2019 10032031 Exp. 12/27/2019 10032033 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031755 Exp. 12/26/2019 10031756 Exp. 12/26/2019 10031940 Exp. 12/26/2019 10031941 Exp. 12/26/2019 10031943 Exp. 12/26/2019 10031944 Exp. 12/26/2019 10031945 Exp. 12/26/2019 10032005 Exp. 12/27/2019 10032032 Exp. 12/27/2019 10032035 Exp. 12/27/2019 10031754 Exp. 12/26/2019 10031942 Exp. 12/26/2019 10031970 Exp. 12/29/2019 10031971 Exp. 12/29/2019 10031972 Exp. 12/29/2019 10031973 Exp. 12/29/2019 10032273 Exp. 12/30/2019 10032274 Exp. 12/30/2019 10032329 Exp. 12/31/2019 10032330 Exp. 12/31/2019 10032812 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032004 Exp. 12/27/2019 10032028 Exp. 12/27/2019 10032029 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10032502 Exp. 1/5/2020 10032029 Exp. 12/27/2019 10032030 Exp. 12/27/2019 10032034 Exp. 12/27/2019 10032813 Exp. 1/6/2020 10033353 Exp. 1/17/2020 10033352 Exp. 1/16/2020 10031753 Exp. 12/26/2019

Distribution pattern

Nationwide.

drug · product 11 of 27

fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1097-43

D-0556-2020
Recall number
D-0556-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029772 Exp. 11/17/2019, 10030627 Exp. 11/22/2019, 10030626 Exp. 11/21/2019, 10030408 Exp. 11/25/2019, 10030512 Exp. 11/27/2019, 10030408 Exp. 11/25/2019, 10031107 Exp. 12/5/2019, 10031268 Exp. 12/10/2019, 10031437 Exp. 12/15/2019, 10031821 Exp. 12/23/2019, 10032285 Exp. 12/30/2019

Distribution pattern

Nationwide.

drug · product 12 of 27

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

D-0557-2020
Recall number
D-0557-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Nationwide.

drug · product 13 of 27

fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1100-50

D-0558-2020
Recall number
D-0558-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029773 Exp. 11/17/2019, 10029821 Exp. 11/18/2019, 10030351 Exp. 11/21/2019, 10031014 Exp. 12/2/2019, 10030351 Exp. 11/21/2019, 10030912 Exp. 12/2/2019, 10030569 Exp. 11/28/2019, 10030966 Exp. 12/3/2019, 10031796 Exp. 12/23/2019, 10031509 Exp. 12/17/2019, 10031067 Exp. 12/5/2019, 10031156 Exp. 12/16/2019

Distribution pattern

Nationwide.

drug · product 14 of 27

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 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 70092-1255-75

D-0559-2020
Recall number
D-0559-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029914 Exp. 11/20/2019, 10030342 Exp. 11/24/2019, 10030948 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10030949 Exp. 12/3/2019, 10030895 Exp. 12/2/2019, 10031377 Exp. 12/6/2019, 10031141 Exp. 12/9/2019, 10031423 Exp. 12/15/2019, 10031627 Exp. 12/19/2019, 10031709 Exp. 12/22/2019, 10031907 Exp. 12/25/2019, 10032022 Exp. 12/27/2019, 10031858 Exp. 12/24/2019, 10032381 Exp. 1/1/2020, 10032296 Exp. 12/31/2019, 10032268 Exp. 12/30/2019, 10032467 Exp. 1/2/2020, 10032674 Exp. 1/8/2020, 10032569 Exp. 1/6/2020, 10032570 Exp. 1/6/2020, 10032516 Exp. 1/5/2020, 10032517 Exp. 1/5/2020, 10032674 Exp. 1/8/2020, 10032570 Exp. 1/6/2020, 10032675 Exp. 1/8/2020, 10033019 Exp. 1/15/2020,

Distribution pattern

Nationwide.

drug · product 15 of 27

fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44

D-0560-2020
Recall number
D-0560-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10030458 Exp. 11/26/2019, 10031113 Exp. 12/5/2019, 10031305 Exp. 12/11/2019, 10031417 Exp. 12/15/2019, 10031765 Exp. 12/26/2019, 10032259 Exp. 12/30/2019

Distribution pattern

Nationwide.

drug · product 16 of 27

fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride , 100 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1108-36

D-0561-2020
Recall number
D-0561-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029291 Exp. 11/14/2019 10029292 Exp. 11/14/2019 10029977 Exp. 11/20/2019 10030041 Exp. 11/21/2019 10029977 Exp. 11/20/2019 10029978 Exp. 11/21/2019 10029979 Exp. 11/21/2019 10030041 Exp. 11/21/2019 10030043 Exp. 11/21/2019 10030396 Exp. 11/25/2019 10030960 Exp. 12/2/2019 10030961 Exp. 12/4/2019 10030962 Exp. 12/4/2019 10031010 Exp. 12/4/2019 10031011 Exp. 12/4/2019 10031012 Exp. 12/4/2019 10030960 Exp. 12/2/2019 10031086 Exp. 12/6/2019 10030960 Exp. 12/2/2019 10031263 Exp. 12/10/2019 10031262 Exp. 12/10/2019 10031413 Exp. 12/15/2019 10031463 Exp. 12/16/2019 10031696 Exp. 12/22/2019 10031947 Exp. 12/26/2019 10031948 Exp. 12/31/2019 10032414 Exp. 1/2/2020 10031978 Exp. 1/1/2020 10031948 Exp. 12/31/2019 10032412 Exp. 1/2/2020 10032413 Exp. 1/2/2020 10032687 Exp. 1/8/2020 10032723 Exp. 1/9/2020 10033037 Exp. 1/23/2020 10032929 Exp. 1/26/2020

Distribution pattern

Nationwide.

drug · product 17 of 27

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

D-0562-2020
Recall number
D-0562-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Nationwide.

drug · product 18 of 27

fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1094-36

D-0563-2020
Recall number
D-0563-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029201 Exp. 11/17/2019, 10029983 Exp. 11/22/2019, 10029987 Exp. 11/22/2019, 10030428 Exp. 11/26/2019, 10030879 Exp. 11/28/2019, 10031240 Exp. 12/10/2019, 10031241 Exp. 12/10/2019, 10031344 Exp. 12/12/2019, 10031343 Exp. 12/12/2019, 10031394 Exp. 12/12/2019, 10031612 Exp. 12/19/2019, 10031665 Exp. 12/20/2019, 10031666 Exp. 12/20/2019, 10031590 Exp. 12/18/2019, 10031787 Exp. 12/23/2019, 10032036 Exp. 12/27/2019, 10032305 Exp. 12/31/2019, 10032444 Exp. 1/2/2020, 10033172 Exp. 1/12/2020

Distribution pattern

Nationwide.

drug · product 19 of 27

fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/mL) in 0.9% Sodium Chloride 200 mL CADD, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1441-76

D-0564-2020
Recall number
D-0564-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029361 Exp. 11/15/2019, 10029362 Exp. 11/15/2019, 10029334 Exp. 11/14/2019, 10029855 Exp. 11/19/2019, 10029856 Exp. 11/19/2019, 10030387 Exp. 11/25/2019, 10030388 Exp. 11/25/2019, 10031026 Exp. 12/12/2019, 10031078 Exp. 12/12/2019, 10031469 Exp. 12/16/2019, 10031493 Exp. 12/16/2019, 10031519 Exp. 12/17/2019, 10031804 Exp. 12/23/2019, 10031105 Exp. 12/12/2019, 10031830 Exp. 12/23/2019, 10031884 Exp. 12/24/2019, 10032704 Exp. 1/8/2020, 10032888 Exp. 1/12/2020, 10032889 Exp. 1/12/2020, 10032913 Exp. 1/13/2020, 10032939 Exp. 1/13/2020, 10032940 Exp. 1/13/2020

Distribution pattern

Nationwide.

drug · product 20 of 27

fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36

D-0565-2020
Recall number
D-0565-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029200 Exp. 11/18/2019, 10030347 Exp. 11/24/2019, 10031325 Exp. 12/16/2019, 10030939 Exp. 12/3/2019, 10031865 Exp. 12/24/2019, 10031758 Exp. 12/26/2019, 10031757 Exp. 12/26/2019, 10032275 Exp. 12/30/2019

Distribution pattern

Nationwide.

drug · product 21 of 27

fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47

D-0566-2020
Recall number
D-0566-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10030359 Exp. 11/21/2019, 10030549 Exp. 11/28/2019, 10031169 Exp. 12/8/2019, 10031491 Exp. 12/16/2019, 10031879 Exp. 12/24/2019, 10032317 Exp. 12/31/2019, 10032265 Exp. 12/30/2019

Distribution pattern

Nationwide.

drug · product 22 of 27

fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1444-05

D-0567-2020
Recall number
D-0567-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029186 Exp. 11/18/2019, 10029791 Exp. 11/18/2019, 10030403 Exp. 11/25/2019, 10030456 Exp. 11/27/2019, 10030910 Exp. 12/2/2019, 10030403 Exp. 11/25/2019, 10031154 Exp. 12/8/2019, 10031238 Exp. 12/10/2019, 10031182 Exp. 12/9/2019, 10031130 Exp. 12/8/2019, 10031483 Exp. 12/16/2019, 10031482 Exp. 12/16/2019, 10031621 Exp. 12/19/2019, 10031592 Exp. 12/19/2019, 10031921 Exp. 12/25/2019, 10031869 Exp. 12/24/2019, 10032219 Exp. 12/29/2019, 10032393 Exp. 1/1/2020, 10032369 Exp. 1/1/2020, 10032561 Exp. 1/6/2020, 10032586 Exp. 1/6/2020, 10031898 Exp. 12/26/2019

Distribution pattern

Nationwide.

drug · product 23 of 27

fentaNYL 800 mcg/200 mL (4 mcg/mL) BUPivacaine HCl 0.1667% 333.4 mg/200 mL (1.667 mg/mL) in 0.9% Sodium Chloride 200 mL in 250 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

D-0568-2020
Recall number
D-0568-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10029972 Exp. 11/21/2019, 10030562 Exp. 11/28/2019, 10031447 Exp. 12/15/2019, 10031341 Exp. 12/15/2019, 10031630 Exp. 12/19/2019, 10031748 Exp. 12/22/2019, 10032817 Exp. 1/8/2020, 10033208 Exp. 1/19/2020, 10032887 Exp. 1/12/2020

Distribution pattern

Nationwide.

drug · product 24 of 27

fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76

D-0569-2020
Recall number
D-0569-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10030890 Exp. 12/2/2019, 10031264 Exp. 12/10/2019, 10031093 Exp. 12/6/2019, 10032337 Exp. 12/31/2019

Distribution pattern

Nationwide.

drug · product 25 of 27

fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1180-79

D-0570-2020
Recall number
D-0570-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10030060 Exp. 11/21/2019, 10030574 Exp. 11/28/2019, 10031353 Exp. 12/12/2019, 10031677 Exp. 12/20/2019, 10031622 Exp. 12/19/2019, 10031419 Exp. 12/15/2019, 10031769 Exp. 12/26/2019, 10031826 Exp. 12/23/2019, 10032287 Exp. 12/30/2019

Distribution pattern

Nationwide.

drug · product 26 of 27

fentaNYL 1000 mcg/100 mL (10 mcg/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 70092-1250-75

D-0571-2020
Recall number
D-0571-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lots: 10030341 11/24/2019, 10031102 12/6/2019, 10031555 Exp. 12/18/2019, 10031554 Exp. 12/18/2019, 10031803 Exp. 12/23/2019, 10031776 Exp. 12/22/2019, 10032266 Exp. 12/30/2019, 10032267 Exp. 12/30/2019, 10032321 Exp. 12/31/2019, 10032320 Exp. 12/31/2019, 10032544 Exp. 1/5/2020, 10032515 Exp. 1/5/2020

Distribution pattern

Nationwide.

drug · product 27 of 27

fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1274-50

D-0572-2020
Recall number
D-0572-2020
Initiated
November 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
QuVa Pharma, Inc.
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot: 10031855 Exp. 12/24/2019

Distribution pattern

Nationwide.