Mylan Recalls Alprazolam Tablets Due to Foreign Substance Presence
Mylan Pharmaceuticals is recalling Alprazolam 0.5 mg tablets because they contain a foreign substance. Consumers should stop using the affected lot and contact their pharmacist.
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, which corresponds to a Severe severity score per the rubric, as it involves a potential health risk that may cause temporary or medically reversible harm.
Plain-English summary
Mylan Pharmaceuticals Inc. is voluntarily recalling 5,760 bottles of Alprazolam Tablets, USP 0.5 mg, 500-count bottles. The recall is due to the presence of a foreign substance in the product. The affected product is identified by Lot # 8082708 and has an expiration date of September 2020.
The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed nationwide within the United States. Alprazolam is a prescription-only medication.
Consumers who have this specific lot of Alprazolam tablets should stop using them and contact their pharmacist or healthcare provider for further instructions. The product should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,760
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 #: 8082708
- Exp. Date September 2020
Distribution
Distributed nationwide across the United States.
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