Alprazolam 2 mg tablets recalled due to potential manufacturing cross-contamination
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential cross-contamination at the manufacturer. Nine bottles distributed nationwide; affected lots include 03FE2319 and 13MY2217.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II precautionary recall with no reported illnesses, injuries, or deaths. The potential cross-contamination hazard is theoretical and unconfirmed, meeting criteria for Score 2 (Moderate) voluntary precautionary recalls.
Plain-English summary
Direct Rx is recalling Alprazolam C-IV 2 mg tablets (NDC 72189-121-60) due to potential product cross-contamination at the manufacturer. The company identified Current Good Manufacturing Practice (CGMP) deviations that posed a cross-contamination risk.
The recalled product was distributed nationwide. The recall involves 9 bottles with lot numbers 03FE2319 (Expiration 2/28/25) and 13MY2217 (Expiration 5/31/23).
Patients and healthcare providers who may have the affected product should verify the lot number and NDC number to determine if their medication is included in this recall.
The recalled product
- Product
- Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.
- Manufacturer
- Direct Rx
- Category
- Drug — Benzodiazepine
- Affected units
- 9
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)
- Lots: 03FE2319 Exp. 2/28/25
- 13MY2217 Exp. 5/31/23
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Direct Rx 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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