fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1...
FDA Drug Recall #D-0555-2020 — Class II — November 12, 2019
Recall Summary
| Recall Number | D-0555-2020 |
| 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 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
Reason for Recall
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Distribution Pattern
Nationwide.
Lot / 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
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.