Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
National Drug Code
Is NDC 65862-0053-99 recalled?
Simvastatin · 1000 TABLET, FILM COATED in 1 BOTTLE (65862-053-99)
Yes — this exact package was recalled
1 FDA recall names the code 65862-0053-99 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Simvastatin
- Strength
- SIMVASTATIN 40 mg/1
- Form
- Tablet, Film Coated
- Labeler
- Aurobindo Pharma Limited
- Type
- Drug for Further Processing
- Product code
- 65862-0053
Recalls naming this package
Class III · Low risk
Simvastatin Tablets
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 65862-0420 Sulfamethoxazole and Trimethoprim 2
- 65862-0573 Valsartan 2
- 65862-0739 Amlodipine and valsartan 2
- 65862-0840 Moxifloxacin 2
- 65862-0010 Metformin Hydrochloride 1
- 65862-0041 Lisinopril 1
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