UDL Recalls Hydrocodone and Acetaminophen Tablets Due to Potency Issues

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling 3,407 cartons of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg. The product is packaged as 100 tablets per carton (5 cards of 20 blistered tablets) and is distributed nationwide. The affected lots are 3037841, 3040859, and 3042573, all with an expiration date of 12/13.

The recall was initiated because the tablets are oversized, which has resulted in superpotent assays of both the hydrocodone and acetaminophen components. This means the tablets contain higher amounts of the active ingredients than intended.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc.,

Manufacturer

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

Category

Drug — Prescription Medication

Hazard

• superpotent-assay
• oversized-tablets

Affected units

3,407

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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