Mylan Recalls Fexofenadine HCl Tablets Due to Impurity Failures
Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 60 mg tablets because they failed impurity specifications. The recall covers 13,856 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 13,856 bottles of Fexofenadine HCl Tablets, USP, 60 mg. The affected products are sold in 60-count bottles (NDC 0378-0781-91) and 500-count bottles (NDC 0378-0781-05). The specific lot number is 3047303, with an expiration date of 04/2015. The products were distributed nationwide.
The recall was initiated because the tablets failed impurity and degradation specifications. Specifically, out-of-specification results were found for a related compound, which is a degradant of fexofenadine.
Consumers who have these specific bottles should stop using the product and contact their pharmacist or Mylan Pharmaceuticals for further instructions.
The recalled product
- Product
- Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV…
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 13,856
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3047303
- Exp 04/2015
Distribution
Distributed nationwide across the United States.
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