D-0506-2019 Class III Terminated
FDA drug recall D-0506-2019 was initiated by Mylan Pharmaceuticals Inc. on Feb 13, 2019 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing The recall status is terminated (terminated Sep 12, 2019). Affected quantity: 8,159 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 27, 2019
- Initiation Date
- Feb 13, 2019
- Termination Date
- Sep 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,159 bottles
Product description
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
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Distribution pattern
Throughout the United States
Code information
Lot #: 3090167, Exp. October 2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0506-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026