Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities
Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to 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 source text explicitly identifies the recall as FDA 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 Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, USP 120 mg. The product is identified by NDC 51079-947-08 and Batch 3096049. Each carton contains 80 capsules arranged in 8 blister cards of 10 capsules each.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for a related compound. 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 affected product was distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for the specific NDC and batch number listed above. If found, the product should be returned to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- Product
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 408
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 (1)
- Batch 3096049
Distribution
Distributed nationwide across the United States.
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