The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0151-2017·Announced 2016-11-30

Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules because of out-of-specification results for a known compound.

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 as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because adverse health consequences are unlikely.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Diltiazem HCl Extended-Release Capsules, USP 120 mg. The affected products are available in 100-count and 500-count bottles and are prescription-only. The recall covers approximately 51,983 capsules distributed nationwide.

The recall was initiated due to failed impurities and degradation specifications, specifically out-of-specification (OOS) results for a known compound. The agency has classified this recall as Class III, indicating that there is a remote possibility that adverse health consequences may be serious or permanently life-threatening, or that adverse health consequences are not likely to occur.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Cardiovascular
Hazard
Affected units
51,983

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 (6)

  • 0378-5220-01 Lot# 3065133
  • Exp. 03/17 0378-5220-01 Lot# 3066564
  • Exp. 05/17 0378-5220-05 Lot# 3066564
  • Exp. 05/17 0378-5220-01 Lot# 3069645
  • Exp. 08/17 0378-5220-05 Lot# 3069645
  • Exp. 08/17

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Mylan Pharmaceuticals Inc.

See all →

Same hazard · impurities

See all →

Similar recalls