Drug product
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
D-1842-2019
Product summary
- Event
- Event 83436
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,352/1000 count bottles
- Official record key
drug-enforcement:D-1842-2019
Official wording
Reason: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Code information: 05318054B, exp 3/2021
Distribution pattern: Product was distributed nationwide by three major distributors who may have further distributed the product.
Derived failure modes
-
Labeling or packaging
Labeling; Incorrect or Missing