FDAClass IIIFebruary 20, 2019

Diltiazem HCl CD capsules recall: Failed Dissolution

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North…

Why was Diltiazem HCl CD capsules recalled?

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020

Product
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North…
Recalling firm
Valeant Pharmaceuticals North America LLC
Quantity
23,884 bottles
Distribution
Nationwide in the USA and Puerto Rico
Recall date
February 20, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls