D-1084-2014 Class II Terminated
FDA drug recall D-1084-2014 was initiated by Mylan Pharmaceuticals Inc. on Jan 14, 2014 and is designated Class II. Reason for recall: Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. The recall status is terminated (terminated Oct 14, 2015). Affected quantity: 138,970 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 19, 2014
- Initiation Date
- Jan 14, 2014
- Termination Date
- Oct 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 138,970 bottles
Product description
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01
Reason for recall
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Distribution pattern
Nationwide.
Code information
Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1084-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026