Recalls / Class I
Class ID-0856-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / code info
- Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Why it was recalled
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Recalling firm
- Firm
- Fagron, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118
Distribution
- Quantity
- a) 559 bottles and b) 243 bottles
- Distribution pattern
- Nationwide USA and Puerto Rico, Canada, Columbia, France
Timeline
- Recall initiated
- 2022-03-04
- FDA classified
- 2022-05-09
- Posted by FDA
- 2022-05-18
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0856-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.