FDA Drug recall D-0491-2019
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceut…
- FDA Drug
- Class III
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class III recall of Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceut… by Valeant Pharmaceuticals North America, citing failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0491-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-30 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
Product
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Identifiers
| code_info | Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.