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.
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 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
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