Recall events
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Event 95190
Event summary
Timeline bucket August 22, 2024
Product types Drug
Classifications Class II
Statuses Ongoing
Recalling firm wording ProRx LLC
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
7 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 7
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
D-0650-2024
Recall number D-0650-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 2,490 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[818]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 7
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
D-0651-2024
Recall number D-0651-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 37 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot # ProRx040924-1, BUD 10/08/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[807]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 7
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
D-0652-2024
Recall number D-0652-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 8,396 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[817]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 7
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
D-0653-2024
Recall number D-0653-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 1,960 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information ProRx061424, BUD 12/13/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[824]
FDA event record
· Exact recall-number query on openFDA
drug · product 5 of 7
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
D-0654-2024
Recall number D-0654-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 500 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot # ProRx031924-1, BUD 09/18/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[800]
FDA event record
· Exact recall-number query on openFDA
drug · product 6 of 7
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
D-0655-2024
Recall number D-0655-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 1,489 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot # ProRx051424, BUD 11/13/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[802]
FDA event record
· Exact recall-number query on openFDA
drug · product 7 of 7
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
D-0656-2024
Recall number D-0656-2024
Initiated August 22, 2024
Classification Class II
Status Ongoing
Quantity 1,732 vials
App-derived interpretation
Sterility assurance
reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall Lack of Assurance of Sterility
Code information Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
Distribution pattern Nationwide in the USA
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[798]
FDA event record
· Exact recall-number query on openFDA
