SyrSpend SF Suspending Base Recalled for Burkholderia Contamination
Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored (NDC 51552-1123-5 and 51552-1123-9) due to contamination with Burkholderia gladioli. This FDA Class I recall affects medication used in compounding.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which per the rubric requires a minimum severity score of 4 (Severe). Although the hazard is serious, no illnesses or injuries have been reported in the source material.
Plain-English summary
SyrSpend SF Suspending Base, Cherry Flavored, manufactured for Fagron, Inc., is being recalled due to microbial contamination. The product is available in two package sizes: 500mL bottles (NDC 51552-1123-5) and 4L bottles (NDC 51552-1123-9), both in lots A67185 and A67186 with expiration date 08/31/2024.
The recalled product is contaminated with Burkholderia gladioli, a pathogenic bacterium. The FDA has classified this as a Class I recall, indicating the product poses a serious health risk.
The product was distributed nationwide in the USA and Puerto Rico, as well as to Canada, Colombia, and France. Consumers should not use this product.
The recalled product
- 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.
- Manufacturer
- Fagron, Inc
- Category
- Drug — Pharmaceutical Base
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) A67185
- Exp. Date 08/31/2024
- b) Lot #: A67186
Distribution
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