The Recall Desk
HighFDA (Drugs)·D-0507-2023·Announced 2023-04-12

Alprazolam 0.5 mg tablets recalled due to manufacturing contamination

Direct Rx is recalling Alprazolam 0.5 mg tablets (Lot 11AP2219, expires 4/30/23) nationwide due to potential cross-contamination concerns at the manufacturer. No illnesses have been reported.

What this means for you

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 potential cross-contamination at the manufacturer with no reported illnesses or injuries. Since the hazard is theoretical and actual harm has not manifested, the severity is High rather than Severe.

Plain-English summary

Direct Rx is recalling Alprazolam C-IV 0.5 mg tablets in 30-tablet bottles, Lot 11AP2219 (expiration 4/30/23), NDC 72189-0240-30. The recall involves 20 bottles distributed nationwide in the USA.

The recall was initiated due to potential cross-contamination concerns identified at the manufacturer's facility. The repackaging firm discovered quality deviations in the manufacturing process (CGMP deviations) that could have allowed cross-contamination of the product.

Alprazolam is a prescription controlled substance used to treat anxiety disorders. Patients who have received affected bottles should contact their healthcare provider or pharmacy with questions about their medication. Do not discontinue use without consulting a healthcare professional.

Healthcare providers and pharmacies should check their inventory for Lot 11AP2219 and follow Direct Rx's instructions regarding the affected product. Consumers may contact Direct Rx or their pharmacy for information or to arrange return or replacement of the affected bottles.

The recalled product

Product
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.
Manufacturer
Direct Rx
Category
Drug
Hazard
Affected units
20

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 (1)

  • Lot: 11AP2219 Exp. 4/30/23

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Direct Rx

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Same hazard · cross contamination

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