Drug recall D-1842-2019
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
Reason for recall
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Lots and codes
05318054B, exp 3/2021
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 2,352/1000 count bottles
- Distribution
- Product was distributed nationwide by three major distributors who may have further distributed the product.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 29, 2019
- Terminated
- October 28, 2021
Related products
- Simvastatin – drug information
- NDC 65862-050 Simvastatin · Simvastatin 5 mg/1 · Aurobindo Pharma Limited
- NDC 65862-053 Simvastatin · Simvastatin 40 mg/1 · Aurobindo Pharma Limited
- NDC 65862-051 Simvastatin · Simvastatin 10 mg/1 · Aurobindo Pharma Limited
- NDC 65862-054 Simvastatin · Simvastatin 80 mg/1 · Aurobindo Pharma Limited
- NDC 65862-052 Simvastatin · Simvastatin 20 mg/1 · Aurobindo Pharma Limited