D-0553-2020 Class II Terminated
FDA drug recall D-0553-2020 was initiated by QuVa Pharma, Inc. on November 12, 2019 and is designated Class II. Reason for recall: Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules The recall status is terminated (terminated June 5, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2019
- Initiation Date
- November 12, 2019
- Termination Date
- June 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
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