Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
CellCept (mycophenolate mofetil)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Short Fill: some bottles contained less than 120-count per labeled claim.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.
Affected NDCs
0004-0259-05
0004-0259-51
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 |
|---|---|---|---|---|
| CellCept Mycophenolate Mofetil NDC 00004-0259 |
250 mg/1 | Capsule Oral |
Genentech, Inc. | Rx |
- Recalling firm
- Genentech, Inc.
- NDC code
- 0004-0259-05
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-097-2013 · 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 Genentech, Inc.
All 2012 recalls
Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Class III · Low risk
Susvimo (ranibizumab injection)
Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class III · Low risk
Evrysdi (risdiplam)
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
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