D-1186-2018 Class III Terminated
FDA drug recall D-1186-2018 was initiated by Mylan Pharmaceuticals Inc. on Aug 7, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound. The recall status is terminated (terminated Aug 14, 2019). Affected quantity: 11,799 bottles of 100.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 19, 2018
- Initiation Date
- Aug 7, 2018
- Termination Date
- Aug 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,799 bottles of 100
Product Description
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Distribution Pattern
Distributed Nationwide in the US
Code Information
Batch code # 3093163, expiration date 04/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1186-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026