D-1435-2014 Class III Terminated
FDA drug recall D-1435-2014 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Jul 3, 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 26, 2016). Affected quantity: 1,184 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 23, 2014
- Initiation Date
- Jul 3, 2014
- Termination Date
- Jul 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,184 cartons
Product Description
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Reason for Recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Distribution Pattern
Nationwide, Puerto Rico, and Guam.
Code Information
Lot #: 3045659, 3048256, 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-1435-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026