Why it was recalled
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Product description
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
Lot numbers, UPCs & expiration codes
a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020
Where it was sold
Nationwide, 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-0547-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 14, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0547-2018, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Terminated
- Country
- United States
- Event ID
- 79253
- Address
- 2400 Pilot Knob Rd
- Code information
- a) 17I28-U80-039976, exp. 10/02/2020; b) 17I28-U80-039977, exp. 10/02/2020
- Postal code
- 55120-1118
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0547-2018
- Classification
- Class II
- Recalling firm
- Fagron, Inc
- Product quantity
- a) 1007 bottles (500 mL) and b) 738 bottles (4 L)
- Termination date
- Sep 10, 2019
- Reason for recall
- Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
- Distribution pattern
- Nationwide, USA
- Recall initiation date
- Feb 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 27, 2018