VistaPharm LLC FDA Recalls

4 recalls on file across drugs, 1 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FClass IIIOct 26, 2023Defective Container: The adaptor does not fit into the neck	Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.	Class IIIDrugs	Oct 26, 2023
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and DistClass IOct 18, 2023Microbial Contamination of Non-Sterile Products: identified	Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.	Class IDrugs	Oct 18, 2023
Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured forClass IIIOct 17, 2023Failed Excipient Specifications: high content of ethylene gl	Failed Excipient Specifications: high content of ethylene glycol (EG)	Class IIIDrugs	Oct 17, 2023
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and DistribuClass IIAug 30, 2023Superpotent/Subpotent single ingredient Drug: Out of Specifi	Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results	Class IIDrugs	Aug 30, 2023