The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0490-2019·Announced 2019-02-20

Valeant Recalls Cardizem CD Capsules for Dissolution Failures

Valeant Pharmaceuticals is recalling 22 bottles of Cardizem CD capsules because they failed to meet 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control issue (dissolution) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Valeant Pharmaceuticals North America LLC is recalling 22 bottles of Cardizem CD (diltiazem hydrochloride) 300 mg capsules. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide in the USA and Puerto Rico. The specific lots involved are 18J020P and 18J034P, both with an expiration date of 08/2020.

The recall was initiated because the capsules failed to meet dissolution specifications. This means that high out-of-specification results were observed when measuring the amount of drug released at certain time points. This defect may affect the consistency of the medication's performance.

Consumers who have these specific lots of Cardizem CD should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is limited to the 22 bottles identified in the source text.

The recalled product

Product
CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Brand
CARDIZEM CD
Manufacturer
Valeant Pharmaceuticals North America LLC
Category
Drug — Prescription Drug
Hazard
Affected units
22

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 (3)

  • Lots: a)18J020P
  • Exp 08/2020
  • b) 18J034P

UPCs (1)

  • 0301870796421

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 →

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