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.
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 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
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.
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