Fagron Recalls SyrSpend SF Grape Flavor Due to Yeast Contamination
Fagron, Inc. is recalling SyrSpend SF Grape Flavor suspending base due to the presence of yeast. The recall affects 148 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves microbial contamination (yeast) in a non-sterile product, which fits the criteria for a high-risk pathogen or risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fagron, Inc. is recalling SyrSpend SF, Suspending Base, Grape Flavored, a sugar-free syrup-suspending vehicle used for extemporaneous preparation of oral liquid dose forms. The recall is being conducted due to the presence of yeast in the product.
The affected product is the 4 L bottle, NDC 51552-1167-9. A total of 148 bottles are involved in this recall. The product was distributed nationwide.
The specific lot numbers affected are 15A05-U03-022765, 15G29-U03-025975, and 15A05-U06-023277. The source text does not specify further instructions for consumers or healthcare providers regarding the disposal or return of the product.
The recalled product
- Product
- SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120…
- Manufacturer
- Fagron, Inc
- Affected units
- 148
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 #s: 15A05-U03-022765
- 15G29-U03-025975
- 15A05-U06-023277
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fagron, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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