Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-Release Capsules 120 mg because routine stability testing revealed out-of-specification results for related compounds.
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 120 mg, 100-count bottles (NDC 0378-5220-01). The recall involves 11,799 bottles with batch code # 3093163 and an expiration date of 04/2019. The product was distributed nationwide in the US.
The recall was initiated because routine stability testing produced out-of-specification test results for related compounds. This indicates a failure to meet impurities and degradation specifications.
The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. Consumers with this medication should contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
- 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.
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