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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91443

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

Open FDA event record

Event summary

Timeline bucket
December 30, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Northern VA Compounders PLLC

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

25 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 25

Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0102-2023
Recall number
D-0102-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 12062022@7, Exp 1/20/2023; 12072022@32, Exp 1/22/2023

Distribution pattern

Nationwide in the USA

drug · product 2 of 25

QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0103-2023
Recall number
D-0103-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
78 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#: 11182022@1, Exp 1/2/2023; 12012022@9, Exp 1/15/2023; 11142022@8, Exp 12/29/2022; 11292022@10, Exp 1/13/2023

Distribution pattern

Nationwide in the USA

drug · product 3 of 25

QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0104-2023
Recall number
D-0104-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
12 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#: 12012022@11, Exp 1/15/2023

Distribution pattern

Nationwide in the USA

drug · product 4 of 25

QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0105-2023
Recall number
D-0105-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
56 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#: 11162022@7, Exp 12/31/2022

Distribution pattern

Nationwide in the USA

drug · product 5 of 25

TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0106-2023
Recall number
D-0106-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
750 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#: 11142022@17, Exp 12/29/2022; 11262022@7, Exp 1/10/2023; 12022022@3, Exp 1/16/2023

Distribution pattern

Nationwide in the USA

drug · product 6 of 25

QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0107-2023
Recall number
D-0107-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
39 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#: 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023

Distribution pattern

Nationwide in the USA

drug · product 7 of 25

QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0108-2023
Recall number
D-0108-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
6 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#: 12062022@1, Exp 1/20/2023

Distribution pattern

Nationwide in the USA

drug · product 8 of 25

Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0109-2023
Recall number
D-0109-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
4 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#: 12012022@7, Exp 1/15/2023

Distribution pattern

Nationwide in the USA

drug · product 9 of 25

Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0110-2023
Recall number
D-0110-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
4 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#: 11212022@5, Exp 1/5/2023

Distribution pattern

Nationwide in the USA

drug · product 10 of 25

Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0111-2023
Recall number
D-0111-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
108 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#: 11252022@12, Exp 1/9/2023

Distribution pattern

Nationwide in the USA

drug · product 11 of 25

Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0112-2023
Recall number
D-0112-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 12052022@11, Exp 1/19/2023

Distribution pattern

Nationwide in the USA

drug · product 12 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0113-2023
Recall number
D-0113-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 11142022@12, Exp 12/29/2022

Distribution pattern

Nationwide in the USA

drug · product 13 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0114-2023
Recall number
D-0114-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
4 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#: 11142022@11, Exp 12/29/2022

Distribution pattern

Nationwide in the USA

drug · product 14 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0115-2023
Recall number
D-0115-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 11182022@2, Exp 1/2/2023

Distribution pattern

Nationwide in the USA

drug · product 15 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0116-2023
Recall number
D-0116-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
4 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#: 11212022@7, Exp 1/5/2023

Distribution pattern

Nationwide in the USA

drug · product 16 of 25

TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0117-2023
Recall number
D-0117-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
525 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#: 11252022@5, Exp 1/9/2023; 12012022@12, Exp 1/15/2023

Distribution pattern

Nationwide in the USA

drug · product 17 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0118-2023
Recall number
D-0118-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
8 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#: 11262022@8, Exp 1/10/2023; 11302022@12, Exp 1/14/2023

Distribution pattern

Nationwide in the USA

drug · product 18 of 25

Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0119-2023
Recall number
D-0119-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 11292022@16, Exp 1/13/2023

Distribution pattern

Nationwide in the USA

drug · product 19 of 25

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0120-2023
Recall number
D-0120-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 11292022@12, Exp 1/13/2023

Distribution pattern

Nationwide in the USA

drug · product 20 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0121-2023
Recall number
D-0121-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
8 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#: 11252022@15, Exp 1/9/2023; 11302022@9, Exp 1/14/2023; 12022022@5, Exp 1/16/2023

Distribution pattern

Nationwide in the USA

drug · product 21 of 25

BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0122-2023
Recall number
D-0122-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
4 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#: 12062022@3, Exp 1/20/2023

Distribution pattern

Nationwide in the USA

drug · product 22 of 25

TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0123-2023
Recall number
D-0123-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
36 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#: 12062022@4, Exp 1/20/2023

Distribution pattern

Nationwide in the USA

drug · product 23 of 25

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0124-2023
Recall number
D-0124-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 12082022@8, Exp 1/22/2023

Distribution pattern

Nationwide in the USA

drug · product 24 of 25

BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0125-2023
Recall number
D-0125-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
1200 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#: 10252022@3, Exp 1/31/2023

Distribution pattern

Nationwide in the USA

drug · product 25 of 25

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

D-0126-2023
Recall number
D-0126-2023
Initiated
December 30, 2022
Classification
Class II
Status
Terminated
Quantity
2 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#: 11212022@8, Exp 1/5/2023

Distribution pattern

Nationwide in the USA