Mylan Recalls Carisoprodol Tablets Due to Failed Impurity Specification

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 3,252 cartons of Carisoprodol Tablets, USP, 350 mg, unit dose blister packages. The product is manufactured for Qualitest Pharmaceuticals and is distributed nationwide in the United States. The recall is being conducted because the product failed an impurity or degradation specification.

The affected product is identified by NDC 51079-819-20. The specific lots and expiration dates involved are: 3037463 (Expires 2/2014), 3039466 (Expires 3/2014), 3040644 (Expires 4/2014), 3043463 (Expires 6/2014), and 3049568 (Expires 3/2015).

This recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates and stop using the product if it matches the recalled description.

The recalled product

Product

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20

Manufacturer

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

Category

Drug — Prescription Medication

Hazard

• impurity

Affected units

3,252

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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