Diltiazem HCl Extended-Release Capsules recall: Impurity Out of Spec
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
Why was Diltiazem HCl Extended-Release Capsules recalled?
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3090167, Exp. October 2019
- 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
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 8,159 bottles
- Distribution
- Throughout the United States
- Recall date
- February 27, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)