Mylan Recalls Doxazosin Tablets Due to Acetaminophen and Codeine Contamination
Mylan Pharmaceuticals is recalling 24,331 bottles of Doxazosin Tablets, USP, 2 mg, due to cross-contamination with acetaminophen and codeine.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of extraneous active pharmaceutical ingredients (acetaminophen and codeine) in a prescription medication poses a significant risk of adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 24,331 bottles of Doxazosin Tablets, USP, 2 mg, 100 count bottles. The recall is due to cross-contamination with other products, specifically acetaminophen and codeine, which were identified during stability testing chromatographic review.
The affected product is Lot A 303M with an expiration date of June 2014. The product was distributed nationwide. The tablets were manufactured in Australia by Alphapharm Pty Ltd for Mylan Pharmaceuticals Inc.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 24,331
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 (2)
- Lot A 303M
- Exp. June 2014
Distribution
Distributed nationwide across the United States.
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