Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89954

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

Open FDA event record

Event summary

Timeline bucket
April 05, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

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

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

ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

D-0775-2022
Recall number
D-0775-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
28 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32618 BUD: 4/4/2022; 34525 BUD: 5/24/2022

Distribution pattern

Nationwide within United States

drug · product 2 of 7

BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

D-0776-2022
Recall number
D-0776-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
778 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32242 BUD: 4/19/2022; 33911 BUD: 6/8/2022

Distribution pattern

Nationwide within United States

drug · product 3 of 7

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

D-0777-2022
Recall number
D-0777-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
189 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32961 BUD: 5/12/2022

Distribution pattern

Nationwide within United States

drug · product 4 of 7

LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

D-0778-2022
Recall number
D-0778-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
25 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 33444 BUD: 4/26/2022

Distribution pattern

Nationwide within United States

drug · product 5 of 7

Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

D-0779-2022
Recall number
D-0779-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
35 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32610 BUD: 4/4/2022; 35126 BUD: 6/7/2022

Distribution pattern

Nationwide within United States

drug · product 6 of 7

PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

D-0780-2022
Recall number
D-0780-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
43 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32616 BUD: 4/4/2022; 34527 BUD: 5/24/2022

Distribution pattern

Nationwide within United States

drug · product 7 of 7

Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

D-0781-2022
Recall number
D-0781-2022
Initiated
April 05, 2022
Classification
Class II
Status
Terminated
Quantity
76 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
deviations from Current Good Manufacturing Practices
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: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Code information

Lot #: 32963 BUD: 4/12/2022; 34824 BUD: 5/30/2022; 35130 BUD: 6/7/2022

Distribution pattern

Nationwide within United States