The Recall Desk
ModerateFDA (Drugs)·D-0650-2022·Announced 2022-03-16

Alprazolam 1 mg recalled for potential cross-contamination at manufacturer

Direct Rx is recalling Alprazolam C-IV 1 mg 60-count bottles due to potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The recall affects 16 bottles distributed to Florida, Georgia, and Louisiana.

What this means for you

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: This is an FDA Class II recall involving a CGMP deviation (potential cross-contamination) at the contract manufacturer. No illnesses, injuries, or deaths are reported in the source text. The recall involves a prescription drug, but the hazard is a manufacturing control issue without documented harm, making it a moderate-severity precautionary action.

Plain-English summary

Direct Rx is recalling Alprazolam C-IV 1 mg in 60-count bottles (NDC 61919-836-60, Lot #19AU1910, expiration 5/31/22) because of potential cross-contamination at the contract manufacturer, Ultra Tab Laboratories Inc. The product is a prescription (Rx Only) controlled substance distributed by Par Pharmaceutical in Chestnut Ridge, NY and packaged/distributed by Direct Rx in Dawsonville, GA.

The recall affects 16 bottles that were distributed to Florida, Georgia, and Louisiana. Consumers who have this medication should not use it and should consult their healthcare provider for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60
Manufacturer
Direct Rx
Category
Drug — Prescription / Controlled Substance
Hazard
Affected units
16

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 #: 19AU1910 Exp. 5/31/22

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Direct Rx

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Same hazard · cross contamination

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