The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0656-2016·Announced 2016-02-17

Fagron Recalls SyrSpend SF Suspending Base Due to Yeast Contamination

Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product contains yeast. The recall covers 88 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is microbial contamination (yeast) in a non-sterile product, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injuries.

Plain-English summary

Fagron, Inc. is recalling SyrSpend SF, Suspending Base, a sweetened, sugar-free syrup-suspending vehicle used for preparing 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, identified by NDC 51552-1079-9. The recall includes 88 bottles from Lot #s 15J26-U05-027457 and 15J26-U05-027473. These products were distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
SyrSpend SF, Suspending Base, 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, NDC 51552-1079-9.
Manufacturer
Fagron, Inc
Category
Drug — Pharmaceutical Excipient
Hazard
Affected units
88

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 (2)

  • Lot #s: 15J26-U05-027457
  • 15J26-U05-027473

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.

See all 3 products in this recall →

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