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
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
Affected NDCs
42517-0020-10
42571-0020-10
Compare with the code on your package — it is the most precise check available.
Drug: Simvastatin Category: Cholesterol Medication
- Recalling firm
- Micro Labs Usa, Inc S
- NDC code
- 42571-0020-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0407-2015 · 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 recalls by Micro Labs Usa, Inc S
All 2014 recalls
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Class II · Moderate risk
Glimepiride Tablets
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Class II · Moderate risk
Losartan Potassium Tablets USP
Failed Content Uniformity Specifications; Dry mix failed blend uniformity.
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