Recalls / Class III
Class IIID-0714-2018
Product
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
- Affected lot / code info
- Lot #: 0115086, Exp. 12/2018
Why it was recalled
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Recalling firm
- Firm
- Mckesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd Nw, N/A, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 4266 cartons
- Distribution pattern
- Nationwide with the US
Timeline
- Recall initiated
- 2018-04-23
- FDA classified
- 2018-05-07
- Posted by FDA
- 2018-05-02
- Terminated
- 2020-10-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0714-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.