Why it was recalled
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Product description
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Lot numbers, UPCs & expiration codes
Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Where it was sold
Nationwide USA and Puerto Rico, Canada, Columbia, France
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-0856-2022
- Classification
- Class I
- Status
- Completed
- Recall initiated
- Mar 4, 2022
- FDA report date
- May 18, 2022
- Quantity
- a) 559 bottles and b) 243 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron, Inc
Original FDA data
Every field from FDA enforcement report D-0856-2022, exactly as published.
Show all FDA fields
- City
- Saint Paul
- State
- MN
- Status
- Completed
- Country
- United States
- Event ID
- 89805
- Address
- 2400 Pilot Knob Rd
- Code information
- Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
- Postal code
- 55120-1118
- Report date
- May 18, 2022
- Product type
- Drugs
- Recall number
- D-0856-2022
- Classification
- Class I
- Recalling firm
- Fagron, Inc
- Product quantity
- a) 559 bottles and b) 243 bottles
- Reason for recall
- Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
- Distribution pattern
- Nationwide USA and Puerto Rico, Canada, Columbia, France
- Recall initiation date
- Mar 4, 2022
- Initial firm notification
- Letter
- Center classification date
- May 9, 2022