Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Simvastatin Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Affected NDCs
24658-0300-10
24658-0300-90
Compare with the code on your package — it is the most precise check available.
Drug: Simvastatin Category: Cholesterol Medication
- Recalling firm
- Biocon Inc
- NDC code
- 24658-0300-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0817-2016 · 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 Simvastatin recalls
See all
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Other wrong potency / content recalls from 2016
All wrong potency / content recalls
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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