D-0428-2019 Class II Terminated
FDA drug recall D-0428-2019 was initiated by Mylan Pharmaceuticals Inc. on Jan 18, 2019 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. The recall status is terminated (terminated Oct 9, 2019). Affected quantity: 88,090 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Feb 6, 2019
- Initiation Date
- Jan 18, 2019
- Termination Date
- Oct 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,090 bottles
Product description
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Reason for recall
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Distribution pattern
Nationwide in the USA
Code information
Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0428-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026