Agency classClass IIIOur severity:Low FDA (Drugs)·D-0491-2019·Announced 2019-02-20

Valeant Recalls Diltiazem HCl Capsules for Dissolution Failures

Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Valeant Pharmaceuticals North America LLC is recalling 23,884 bottles of Diltiazem HCl CD capsules, 360 mg, 90-count bottles. The product is prescription-only and was manufactured for Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC. The specific lots affected are 18J035P, 18K094P, and 18K093P, all with an expiration date of 09/2020.

The recall was initiated because the capsules failed dissolution specifications. This means the amount of drug released at certain time points was higher than the allowed limits. The affected products were distributed nationwide in the USA and Puerto Rico.

Consumers and healthcare providers should stop using the recalled Diltiazem HCl CD capsules and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

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…
Manufacturer: Valeant Pharmaceuticals North America LLC
Category: Drug — Cardiovascular
Hazard: dissolution-failure
Affected units: 23,884

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Valeant Pharmaceuticals North America LLC

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Same hazard · dissolution failure