Reported Feb 6, 2019 · Terminated
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Pharmaceuticals Inc. · 781 Chestnut Ridge Rd · Morgantown, WV · 26505-2730
Is this the product you have?
- 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 byMylan Pharmaceuticals Inc., Morgantown, WV 26505 USA
- Lot codes and dates
Lot #: a) 30854903085491Exp 04/19b) 30854923085493308549430854953085496Exp 04/19
- Amount recalled
- 88,090 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
This product could cause temporary or reversible health problems — stop using it.
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