Why it was recalled
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
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
Lot numbers, UPCs & expiration codes
05318054B, exp 3/2021
Where it was sold
Product was distributed nationwide by three major distributors who may have further distributed the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1842-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 29, 2019
- FDA report date
- Sep 4, 2019
- Quantity
- 2,352/1000 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1842-2019, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83436
- Address
- 279 Princeton Hightstown Rd
- Code information
- 05318054B, exp 3/2021
- Postal code
- 08520-1401
- Report date
- Sep 4, 2019
- Product type
- Drugs
- Recall number
- D-1842-2019
- Classification
- Class III
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 2,352/1000 count bottles
- Termination date
- Oct 28, 2021
- Reason for recall
- Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide by three major distributors who may have further distributed the product.
- Recall initiation date
- Jul 29, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 26, 2019