The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0508-2023·Announced 2023-04-12

Alprazolam 1 mg tablets recalled due to manufacturing contamination concerns

Direct Rx is recalling Alprazolam 1 mg tablets nationwide due to potential cross contamination at the manufacturer. No illnesses or injuries have been reported.

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: This FDA Class II recall is precautionary in nature, issued due to CGMP deviations and potential cross contamination with no reported illnesses or injuries. It meets the rubric criterion for low-risk contamination and voluntary precautionary recalls.

Plain-English summary

Alprazolam 1 mg tablets packaged in 30-tablet or 60-tablet bottles are being recalled by Direct Rx (Dawsonville, GA 30534). The recall affects approximately 349 bottles distributed nationwide in the United States.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturer. The repackaging firm determined there are potential product cross contamination concerns. No illnesses or injuries have been reported.

Consumers who possess affected Alprazolam tablets should stop using them and contact their healthcare provider or pharmacist for guidance. Consumers can verify whether their product is affected by checking the lot number and expiration date on their bottle against the FDA recall information.

The recalled product

Product
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Manufacturer
Direct Rx
Category
Drug — Benzodiazepine
Hazard
Affected units
349

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 (20)

  • Lots: a) 03FE2318
  • Exp. 8/31/24
  • b) 27FE2315
  • 28FE2313
  • 02MA2306
  • 21SE2201
  • 16NO2216
  • 17NO2216
  • 24FA2314
  • 17FE2203
  • 12AP2204
  • 17MA2205
  • Exp. 3/31/23
  • 21JU2206
  • 22JU2220
  • 12JY2206
  • Exp. 5/31/23
  • 10AU2209
  • Exp. 6/30/23
  • 14DE2215

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 →

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