Why it was recalled
Lack of Assurance of Sterility
Product description
IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Texas
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-0547-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2015
- FDA report date
- Jan 6, 2016
- Quantity
- 5 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walgreens Infusion Services
Original FDA data
Every field from FDA enforcement report D-0547-2016, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72594
- Address
- 14220 Northbrook Dr Ste 100B
- Code information
- All lots within expiry.
- Postal code
- 78232-5045
- Report date
- Jan 6, 2016
- Product type
- Drugs
- Recall number
- D-0547-2016
- Classification
- Class II
- Recalling firm
- Walgreens Infusion Services
- Product quantity
- 5 bags
- Termination date
- Oct 18, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Distribution pattern
- Texas
- Recall initiation date
- Nov 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 30, 2015