Recalls / Class III
Class IIID-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
- Brand name
- Simvastatin
- Generic name
- Simvastatin
- Active ingredient
- Simvastatin
- Route
- Oral
- NDCs
- 65862-050, 65862-051, 65862-052, 65862-053, 65862-054
- FDA application
- ANDA077691
- Affected lot / code info
- 05318054B, exp 3/2021
Why it was recalled
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 2,352/1000 count bottles
- Distribution pattern
- Product was distributed nationwide by three major distributors who may have further distributed the product.
Timeline
- Recall initiated
- 2019-07-29
- FDA classified
- 2019-08-26
- Posted by FDA
- 2019-09-04
- Terminated
- 2021-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1842-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.