Class II · Moderate risk
AcetaZOLAMIDE Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
AcetaZOLAMIDE Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration
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
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Affected NDC
72888-0047-01
Compare with the code on your package — it is the most precise check available.
Drug: Acetazolamide
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 |
|---|---|---|---|---|
| Acetazolamide NDC 72888-0047 |
125 mg/1 | Tablet Oral |
Advagen Pharma Ltd | Rx |
- Recalling firm
- Rubicon Research Private Limited
- NDC code
- 72888-047-01
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0659-2024 · 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.
Other Acetazolamide recalls
See all
Class II · Moderate risk
Acetazolamide active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Acetazolamide
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other recalls by Rubicon Research Private Limited
All 2024 recalls
Class II · Moderate risk
Metoprolol Tartrate Tablets USP
Presence of Foreign Substance: metal in tablet
Class II · Moderate risk
traMADol Hydrochloride Tablets
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
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