Recalls / Class III
Class IIID-0715-2018
Product
Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
- Affected lot / code info
- Lot #: 0114214, Exp. 09/2018
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
- 7656 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-0715-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.