Reported Feb 20, 2019 · Terminated
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for
Valeant Pharmaceuticals North America LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867
Is this the product you have?
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA |
| 2 | By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada |
| 3 | NDC 68682-521-01. |
- Lot codes and dates
- Lots
18J035P18K094P18K093PExp 09/2020
- Lots
- Amount recalled
- 23,884 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Valeant Pharmaceuticals North America LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.