Diltiazem HCl Extended-Release Capsules recall: Impurity Out of Spec
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Why was Diltiazem HCl Extended-Release Capsules recalled?
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
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?
Batch code # 3093163, expiration date 04/2019
- Product
- Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 11,799 bottles of 100
- Distribution
- Distributed Nationwide in the US
- Recall date
- September 19, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)