fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/mL) in 0.9% Sodium Ch...
FDA Drug Recall #D-0546-2020 — Class II — November 12, 2019
Recall Summary
| Recall Number | D-0546-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | QuVa Pharma, Inc. |
| Location | Sugar Land, TX |
| Product Type | Drugs |
Product Description
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
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
Lot / 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
Other Recalls from QuVa Pharma, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0113-2026 | Class II | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDi... | Oct 10, 2025 |
| D-0295-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... | Mar 6, 2025 |
| D-0296-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... | Mar 6, 2025 |
| D-0297-2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /... | Mar 6, 2025 |
| D-1544-2022 | Class III | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added ... | Sep 20, 2022 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.