Exact FDA event identifier

Event 91921

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

Event summary

Timeline bucket: March 13, 2023
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

11 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 11

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0476-2023

Recall number: D-0476-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 90 count: 495 bottles; 30 count: 13 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 .

Distribution pattern

Nationwide in the USA

drug · product 2 of 11

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

D-0477-2023

Recall number: D-0477-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 19 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

Lot, expiry: 19AU2205, exp 12/31/24; 12OC2211, exp 12/31/24

Distribution pattern

Nationwide in the USA

drug · product 3 of 11

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0478-2023

Recall number: D-0478-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 9 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

Lot, expiry: 21JU2210, exp 7/31/23

Distribution pattern

Nationwide in the USA

drug · product 4 of 11

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0479-2023

Recall number: D-0479-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 4 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

Lot, expiry: 22JU2216 , exp 8/31/23

Distribution pattern

Nationwide in the USA

drug · product 5 of 11

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0480-2023

Recall number: D-0480-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 30 count: 4 bottles; 90 count: 172 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/2024; 28JY2102 , exp 1/31/2024; 06AU2103 , exp 1/31/2024 ; 03JA2210 , exp 1/31/2024 ; 14JY2114 , exp 1/31/2024 ; 05NO2106 , exp 2/29/2024 ; 13OC2118 , exp 2/29/2024 ; 08DE2121 , exp 2/29/2024 ;

Distribution pattern

Nationwide in the USA

drug · product 6 of 11

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0481-2023

Recall number: D-0481-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 30 count: 12 bottles; 90 count: 253 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30 count bottles] Lot, expiry: 21JU2112 , exp 9/30/2023 b) [90 count bottles] Lot, expiry: 22DE2113 , exp 1/31/2024; 27JA2235 , exp 3/31/2024; 05AP2224 , exp 7/31/2024 ; 06AU2104 , exp 1/31/2024 ; 08JU2215 , exp 9/30/2024 ; 209AU2109 , exp 1/31/2024 ; 15JU2113 , exp 9/30/2023 ; 21FE2217 , exp 4/30/2024 ; 21OC2115 , exp 2/29/2024 ; 23JY2144 , exp 1/31/2024 ; 25JU2124 , exp 9/30/2023 ; 29AP2219 , exp 7/31/2024 ; 07DE2128 , exp 3/31/2024 .

Distribution pattern

Nationwide in the USA

drug · product 7 of 11

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0482-2023

Recall number: D-0482-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 30 count: 7 bottles; 90 count: 395 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30 count bottles] Lot, expiry: 13DE2111 , exp 3/31/2024 b) [90 count bottles] Lot, expiry: 17NO2116 , exp 1/31/2024 ; 27JA2234 , exp 4/30/2024; 02MA2218, exp 6/30/2024 ; 12MY2211, exp 7/31/2024 ; 13JY2107, exp 10/31/2023; 15AP2221 , exp 7/31/2024 ; 17AU2110 , exp 10/31/2023; 20SE2108 , exp 10/31/2023; 23JU2115 , exp 10/31/2023; 28JY2101 ,exp 10/31/2023; 30JY2101 ,exp 10/31/2023; 05JA2212 , exp 3/31/2024 ; 13DE2130 , exp 3/31/2024 ; 21OC2111, exp 1/31/2024 ; 17NO2116 , exp 3/31/2024 .

Distribution pattern

Nationwide in the USA

drug · product 8 of 11

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0483-2023

Recall number: D-0483-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 51 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23

Distribution pattern

Nationwide in the USA

drug · product 9 of 11

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0484-2023

Recall number: D-0484-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 30 count: 6 bottles; 90 count: 106 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23.

Distribution pattern

Nationwide in the USA

drug · product 10 of 11

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0485-2023

Recall number: D-0485-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 30 count: 5 bottles; 90 count: 53 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 .

Distribution pattern

Nationwide in the USA

drug · product 11 of 11

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

D-0486-2023

Recall number: D-0486-2023
Initiated: March 13, 2023
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 269 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations

Code information

Lot, expiry: 28AP2212 , exp 7/31/2024 ; 24MA2230, exp 7/31/2024; 11JA2203 , exp 3/31/2023; 02FE2217 , exp 2/28/2023; 10DE2126 , exp 2/28/2023; 25MA2201, exp 5/31/2023; 28FE2230, exp 5/31/2023.

Distribution pattern

Nationwide in the USA