The Recall Desk
LowFDA (Drugs)·D-0714-2018·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 because stability testing showed high dissolution results, failing specifications.

What this means for you

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

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.

Plain-English summary

McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles. The recall involves 4,266 cartons of the medication, which is available by prescription only. The product was manufactured by Par Pharmaceutical and distributed nationwide in the United States.

The recall was initiated because high dissolution results were obtained during stability testing, indicating that the product failed to meet dissolution specifications. The affected lot number is 0115086, with an expiration date of 12/2018.

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 healthcare provider for disposal or replacement in accordance with standard recall procedures.

The recalled product

Product
Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
Manufacturer
Mckesson Packaging Services
Category
Drug — Prescription Medication
Hazard
Affected units
4,266

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 #: 0115086
  • 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 →

Related recalls

Same manufacturer · Mckesson Packaging Services

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Same hazard · failed dissolution

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