The Recall Desk
ModerateFDA (Drugs)·D-0716-2018·Announced 2018-05-02

McKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures

McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, 240 mg, because stability testing showed high dissolution results.

What this means for you

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 the rubric associates with scores of 1 or 2. The hazard involves a failure to meet dissolution specifications, which is a quality defect rather than a direct safety hazard like contamination or mislabeling of a common allergen, fitting the 'Moderate' category for minor labeling or quality errors.

Plain-English summary

McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles. The recall involves 2,966 cartons of the medication, which was distributed nationwide in the United States. The specific lot number is 0115087, with an expiration date of 12/2018.

The recall was initiated because high dissolution results were obtained during stability testing, indicating that the product failed to meet dissolution specifications. This means the medication may not release the active ingredient at the intended rate.

Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or replacement. No specific instructions for patient management are provided in the source text.

The recalled product

Product
Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
Manufacturer
Mckesson Packaging Services
Category
Drug — Cardiovascular
Hazard
Affected units
2,966

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 (2)

  • Lot #: 0115087
  • Exp. 12/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Mckesson Packaging Services 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 3 products in this recall →

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