fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodi...
FDA Drug Recall #D-0550-2020 — Class II — November 12, 2019
Recall Summary
| Recall Number | D-0550-2020 |
| 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 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
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
Lot / 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
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.