Class II
Terminated
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.
This recall has been terminated (originally issued February 6, 2019).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- January 18, 2019
- Posted
- February 6, 2019
- Recall Number
- D-0428-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 88,090 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
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