The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1435-2014·Announced 2014-07-23

Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

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 FDA classified this recall as Class III, which by definition indicates the product is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Diltiazem HCl Extended-Release Capsules, USP, 120 mg, packaged in 80 capsules per carton. The recall involves 1,184 cartons of the medication, which is available by prescription only. The affected product is identified by Lot numbers 3045659 and 3048256, with an expiration date of 07/14.

The recall was initiated because routine stability testing revealed high out-of-specification results for a related compound. This indicates that the product failed to meet impurities and degradation specifications. The FDA has classified this recall as Class III, which is the lowest level of recall and indicates that the product is not likely to cause adverse health consequences.

The affected product was distributed nationwide, as well as in Puerto Rico and Guam. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or supplier for credit or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Cardiovascular
Hazard
Affected units
1,184

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)

  • Lot #: 3045659
  • 3048256
  • Exp 07/14

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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