FDAFDA · Food and drugs·Recall number D-1842-2019
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Published September 4, 2019 · Recall initiated: July 29, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SIMVASTATIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Product was distributed nationwide by three major distributors who may have further distributed the product.
- Lot
- 05318054B, exp 3/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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