Why it was recalled
Subpotent Drug: Product may not have the active ingredient present in the bag.
Product description
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
Lot numbers, UPCs & expiration codes
Lot #:30000271, Exp 10/1/18
Where it was sold
Nationwide to hospitals in USA
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-0003-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 27, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 528 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0003-2019, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 80980
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lot #:30000271, Exp 10/1/18
- Postal code
- 77478-2576
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-0003-2019
- Classification
- Class I
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 528 bags
- Termination date
- Apr 2, 2019
- Reason for recall
- Subpotent Drug: Product may not have the active ingredient present in the bag.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
- Distribution pattern
- Nationwide to hospitals in USA
- Recall initiation date
- Aug 27, 2018
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 1, 2018