D-1557-2014 Class III Terminated
FDA drug recall D-1557-2014 was initiated by Mylan Pharmaceuticals Inc. on Jun 19, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. The recall status is terminated (terminated Jul 23, 2015). Affected quantity: 2,658 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Sep 3, 2014
- Initiation Date
- Jun 19, 2014
- Termination Date
- Jul 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,658 Bottles
Product description
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Reason for recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Distribution pattern
Nationwide
Code information
Lot 3040063 Exp. 07/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1557-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026