Why it was recalled
Failed tablet/capsule specification: missing break line on the 5mg tablet.
Product description
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
Lot numbers, UPCs & expiration codes
Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
Where it was sold
U.S. Nationwide and Puerto Rico
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-0478-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2016
- FDA report date
- Feb 22, 2017
- Quantity
- 12896 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0478-2017, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 76105
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot # T04483, T04484, Exp 2/18; T06028, Exp 4/18; T08423, Exp 5/18
- Postal code
- 27703-8446
- Report date
- Feb 22, 2017
- Product type
- Drugs
- Recall number
- D-0478-2017
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 12896 bottles
- Termination date
- Aug 2, 2017
- Reason for recall
- Failed tablet/capsule specification: missing break line on the 5mg tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
- Distribution pattern
- U.S. Nationwide and Puerto Rico
- Recall initiation date
- Dec 20, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2017