Alprazolam 1mg tablets recalled for manufacturing contamination risk
Preferred Pharmaceuticals is recalling Alprazolam 1mg tablets due to manufacturing deviations that created a potential cross-contamination risk. Affected lots expire August 2024.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a pharmaceutical product with manufacturing deviations creating cross-contamination risk. While no illnesses or specific contaminants have been reported, this constitutes a risk-of-harm product with documented integrity defects.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Alprazolam tablets, USP 1mg, in 30-count and 60-count bottles due to manufacturing deviations identified at the supplier, Breckenridge Pharmaceuticals, Inc. These deviations created a potential risk of cross-contamination.
Affected lot numbers are H3122D, A1123R, L0522E, J2622H, I1622F, and H2422E, all expiring August 31, 2024. The recalled product was distributed nationwide in the United States. No illnesses or injuries have been reported.
Patients taking affected tablets should consult their healthcare provider or pharmacist before taking any action. Do not abruptly stop taking Alprazolam without medical guidance, as this can be unsafe. Affected medication should be returned to the dispensing pharmacy.
The recalled product
- Product
- Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Benzodiazepine
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 (8)
- Lot # a) H3122D
- Exp. Date:8/31/2024
- b) Lot #A1123R
- L0522E
- J2622H
- I1622F
- H2422E
- Exp. Date:8/31/2024.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Preferred Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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