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
Reported: September 4, 2019 Initiated: July 29, 2019 #D-1842-2019
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
Details
- Recalling Firm
- Aurobindo Pharma USA Inc.
- Units Affected
- 2,352/1000 count bottles
- Distribution
- Product was distributed nationwide by three major distributors who may have further distributed the product.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 2,352/1000 count bottles.
Why was this product recalled? ▼
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 4, 2019. Severity: Low. Recall number: D-1842-2019.
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