Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Mycophenolate Mofetil for Oral Suspension
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Affected NDC
66689-0307-08
Compare with the code on your package — it is the most precise check available.
Drug: Phenol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mycophenolate Mofetil NDC 66689-0307 |
200 mg/mL | Powder, for Suspension Oral |
VistaPharm, LLC | Rx |
- Recalling firm
- VistaPharm LLC
- NDC code
- 66689-307-08
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0093-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenol recalls
See all
Class II · Moderate risk
Class II · Moderate risk
Unguentine Original Ointment for Burns
CGMP DEVIATIONS
Class II · Moderate risk
Phenol 10%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Phenol
CGMP Deviations
Other recalls by VistaPharm LLC
All 2023 recalls
Class I · High risk
Sucralfate Oral Suspension
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Class III · Low risk
Aminocaproic Acid Oral Solution
Failed Excipient Specifications: high content of ethylene glycol (EG)
Class II · Moderate risk
Sucralfate Oral Suspension 1g per 10mL
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Class II · Moderate risk
Pyridostigmine Bromide Oral Solution
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
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