The Recall Desk
SevereFDA (Drugs)·D-0547-2018·Announced 2018-03-07

Fagron Recalls SyrSpend SF Suspending Base Due to Microbial Contamination

Fagron, Inc. is recalling SyrSpend SF Suspending Base because the product was found to be contaminated with yeast and mold.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination with Aspergillus fumigatus, a pathogen capable of causing serious infections, particularly in immunocompromised individuals.

Plain-English summary

Fagron, Inc. is recalling SyrSpend SF Suspending Base, a prescription-only suspending base available in 500 mL and 4 L bottles. The recall involves 1,007 bottles of the 500 mL size and 738 bottles of the 4 L size. The affected products were distributed nationwide in the United States.

The recall was initiated due to microbial contamination. Testing revealed the presence of yeast and mold, specifically Paecilomyces saturatus and Aspergillus fumigatus. The agency has classified this as a Class II recall.

Consumers and healthcare providers should stop using the affected products and contact Fagron, Inc. or their healthcare provider for further instructions. The specific lot codes and expiration dates for the recalled items are listed in the official recall documentation.

The recalled product

Product
SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
Manufacturer
Fagron, Inc

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)

  • a) 17I28-U80-039976
  • exp. 10/02/2020
  • b) 17I28-U80-039977

Distribution

Distributed nationwide across the United States.