Mylan Recalls Alprazolam Tablets Due to Elevated Impurity Levels

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 10,281 cartons of Alprazolam Tablets, USP, 0.25 mg. The affected product is identified by NDC 51079-788-20 and includes lots 3095198, 3096266, and 3098776, all with an expiration date of 05-2019.

The recall was initiated because elevated levels of a known impurity were detected during a 6-month room temperature stability interval. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide in the United States and in Puerto Rico. 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 pharmacy or distributor for credit or replacement.

The recalled product

Product

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Manufacturer

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

Category

Drug — Prescription Medication

Hazard

• impurity

Affected units

10,281

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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