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Recall Observatory FDA recall evidence

Drug product

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

November 12, 2019

Class II

Product summary

Firm
QuVa Pharma, Inc.
Event
Event 84263
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0548-2020

Official wording

Reason: 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.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate matter