D-0714-2018 Class III Terminated
FDA drug recall D-0714-2018 was initiated by Mckesson Packaging Services on April 23, 2018 and is designated Class III. Reason for recall: Failed Dissolution Specifications. High dissolution results were obtained during stability testing. The recall status is terminated (terminated October 13, 2020). Affected quantity: 4266 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 2, 2018
- Initiation Date
- April 23, 2018
- Termination Date
- October 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4266 cartons
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
Reason for Recall
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Distribution Pattern
Nationwide with the US
Code Information
Lot #: 0115086, Exp. 12/2018