D-1842-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 4, 2019
- Initiation Date
- July 29, 2019
- Termination Date
- October 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,352/1000 count bottles
Product Description
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
Reason for Recall
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Distribution Pattern
Product was distributed nationwide by three major distributors who may have further distributed the product.
Code Information
05318054B, exp 3/2021