Why it was recalled
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Product description
fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
Lot numbers, UPCs & expiration codes
Lots: 10030890 Exp. 12/2/2019, 10031264 Exp. 12/10/2019, 10031093 Exp. 12/6/2019, 10032337 Exp. 12/31/2019
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0569-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 12, 2019
- FDA report date
- Dec 11, 2019
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0569-2020, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84263
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lots: 10030890 Exp. 12/2/2019, 10031264 Exp. 12/10/2019, 10031093 Exp. 12/6/2019, 10032337 Exp. 12/31/2019
- Postal code
- 77478-2576
- Report date
- Dec 11, 2019
- Product type
- Drugs
- Recall number
- D-0569-2020
- Classification
- Class II
- Recalling firm
- QuVa Pharma, Inc.
- Termination date
- Jun 5, 2020
- Reason for recall
- Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1436-76
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 3, 2019