UDL Recalls Hydrocodone and Acetaminophen Tablets Due to Potency Issues
Mylan Institutional, Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Tablets because the tablets are oversized, resulting in superpotent assays of both active ingredients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class I, which mandates a severity score of 5 (Critical) according to the rubric.
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.…
- Category
- Drug — Prescription Medication
- 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.
Lot numbers (4)
- Lot #: 3037841
- 3040859
- 3042573
- Exp 12/13
Distribution
Distributed nationwide across the United States.
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