Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 180mg because routine stability testing found high out-of-specification impurities.
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 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 Diltiazem HCl Extended-Release Capsules, USP 180mg, packaged in 100-count and 500-count bottles. The affected product is Lot #3090167 with an expiration date of October 2019. A total of 8,159 bottles were distributed throughout the United States.
The recall was initiated because high out-of-specification results were obtained during routine stability testing, indicating failed impurities or degradation specifications. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this specific lot of Diltiazem HCl Extended-Release Capsules should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Cardiovascular
- Hazard
- Affected units
- 8,159
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 #: 3090167
- Exp. October 2019
Distribution
Distribution scope not specified by the agency.
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