McKesson Recalls Diltiazem CD Capsules Due to Dissolution Failures
McKesson Packaging Services is recalling Diltiazem CD 180 mg capsules 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 indicates a low risk of adverse health consequences, and the issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a critical allergen.
Plain-English summary
McKesson Packaging Services is recalling Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles. The recall involves 7,656 cartons of the medication, which is manufactured by Actavis and distributed nationwide in the United States. The specific lot number is 0114214, with an expiration date of 09/2018.
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 the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been prescribed this specific lot.
The recalled product
- Product
- Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles, Rx Only Mfg. By: Actavis 60 Columbia Rd., Bldg. B Morristown, NJ 07960. NDC 63739-284-10
- Manufacturer
- Mckesson Packaging Services
- Category
- Drug — Cardiovascular
- Hazard
- Affected units
- 7,656
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 #: 0114214
- Exp. 09/2018
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.
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