Exact FDA event identifier

Event 89749

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 04, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Direct Rx

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0650-2022

Recall number: D-0650-2022
Initiated: March 04, 2022
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 16 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Code information

Lot #: 19AU1910 Exp. 5/31/22

Distribution pattern

FL, GA, LA

drug · product 2 of 2

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60

D-0651-2022

Recall number: D-0651-2022
Initiated: March 04, 2022
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 8 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)

Code information

Lot #: 07NO1901 Exp. 5/31/22

Distribution pattern

FL, GA, LA