Mylan Recalls Diltiazem HCl Extended Release Capsules Due to Impurities
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended Release Capsules because routine stability testing found high levels of a related 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 recall is classified 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 Pharmaceuticals, Inc. is recalling 2,658 bottles of Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles. The affected product is identified by Lot 3040063 with an expiration date of 07/14. The recall was initiated due to high out-of-specification results for a related compound obtained during routine stability testing.
The recalled product was distributed nationwide. This is a prescription-only medication. The source text does not specify the exact number of affected units beyond the total bottle count or provide specific distribution dates.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,658
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)
- Lot 3040063 Exp. 07/14
Distribution
Distributed nationwide across the United States.
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