Why it was recalled
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Product description
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
Lot numbers, UPCs & expiration codes
Lot #: 0115086, Exp. 12/2018
Where it was sold
Nationwide with the US
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-0714-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 23, 2018
- FDA report date
- May 2, 2018
- Quantity
- 4266 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-0714-2018, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 79936
- Address
- 7101 Weddington Rd Nw
- Code information
- Lot #: 0115086, Exp. 12/2018
- Postal code
- 28027-3412
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0714-2018
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 4266 cartons
- Termination date
- Oct 13, 2020
- Reason for recall
- Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
- Distribution pattern
- Nationwide with the US
- Recall initiation date
- Apr 23, 2018
- Initial firm notification
- Letter
- Center classification date
- May 7, 2018