The Recall Desk
LowFDA (Drugs)·D-1187-2018·Announced 2018-09-19

Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

Mylan Pharmaceuticals is recalling 656 bottles of Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing found out-of-specification related compounds.

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 source explicitly states the agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 656 500-count bottles of Diltiazem HCl Extended-Release Capsules, USP 120 mg (NDC 0378-5220-05). The affected product has batch code # 3093163 and an expiration date of 04/2019.

The recall was initiated because routine stability testing resulted in out-of-specification test results for related compounds, which are impurities or degradation products. The agency has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The product was distributed nationwide in the US. Consumers and healthcare providers should check their inventory for the specific batch code and expiration date listed above. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard

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)

  • Batch code # 3093163
  • expiration date 04/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mylan Pharmaceuticals Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Mylan Pharmaceuticals Inc.

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Same hazard · impurities

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