Mylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 1,363 UD Cartons of Fexofenadine Hydrochloride Tablets, USP 60 mg. The product is an allergy, non-drowsy antihistamine containing 100 tablets per carton. The specific NDC is 51079-547-20, and the affected lots are 3051728 and 3053762, both with an expiration date of 4/2015.

The recall was initiated because routine stability testing revealed slightly above specification results for a Related Compound. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the source of supply or disposed of according to local regulations.

The recalled product

Product

Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20

Manufacturer

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Category

Drug — Antihistamine

Hazard

• impurity

Affected units

1,363

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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