Why it was recalled
Lack of Assurance of Sterility
Product description
Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
NY only
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-1772-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Infusion Options, Inc.
Original FDA data
Every field from FDA enforcement report D-1772-2019, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83136
- Address
- 5924 13th Ave
- Code information
- All lots within expiry
- Postal code
- 11219-4934
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1772-2019
- Classification
- Class II
- Recalling firm
- Infusion Options, Inc.
- Termination date
- Mar 21, 2025
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
- Distribution pattern
- NY only
- Recall initiation date
- Jun 12, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 15, 2019