Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Product description
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Lot numbers, UPCs & expiration codes
Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024
Where it was sold
United States including Puerto Rico and Canada
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-0412-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 205,631 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0412-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91657
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024
- Postal code
- 27703-8446
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0412-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 205,631 bottles
- Termination date
- Apr 22, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
- Distribution pattern
- United States including Puerto Rico and Canada
- Recall initiation date
- Feb 7, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2023