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.

FDA recall notice · announced February 6, 2019 · Mylan Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: a) 3085490, 3085491, Exp 04/19; b) 3085492, 3085493, 3085494, 3085495, 3085496, Exp 04/19
Quantity: 88,090 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0428-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.