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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86799

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2020
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Advanced Nutriceuticals, 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

Complete imported group

Every recalled product in this event

17 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 17

CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0128-2021
Recall number
D-0128-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1029202004, Exp 11/29/2020; Lot #1102202001, 102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202003, Exp 12/10/2020; Lot #1112202004, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 2 of 17

FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0129-2021
Recall number
D-0129-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1112202006, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 3 of 17

PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0130-2021
Recall number
D-0130-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1112202006, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 4 of 17

AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0131-2021
Recall number
D-0131-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
3 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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1029202003, Exp 11/29/2020; Lot #1110202002, Exp 12/10/2020; Lot #1112202001, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 5 of 17

BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0132-2021
Recall number
D-0132-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202001, Exp 12/15/2020; Lot #1112202004, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 6 of 17

THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0133-2021
Recall number
D-0133-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #110220200, 1102202009, Exp 12/09/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202008, Exp 12/10/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 7 of 17

IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0134-2021
Recall number
D-0134-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
3 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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot # 1029202005,Exp 11/29/2020; Lot #1102202014, Exp 12/08/2020; Lot #1112202002, Exp 12/12/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 8 of 17

GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0135-2021
Recall number
D-0135-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1112202008, Exp 12/11/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 9 of 17

NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0136-2021
Recall number
D-0136-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1113202002, Exp 01/13/2021; Lot #1102202005, Exp 12/08/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 10 of 17

B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0137-2021
Recall number
D-0137-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1111202001, Exp 01/11/2021

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 11 of 17

DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0138-2021
Recall number
D-0138-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1111202002, Exp 12/11/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 12 of 17

CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0139-2021
Recall number
D-0139-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1110202004 Exp 12/10/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 13 of 17

THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0140-2021
Recall number
D-0140-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
3 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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1110202005, Exp 12/10/2020; Lot #1102202015, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 14 of 17

GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0141-2021
Recall number
D-0141-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1030202010, Exp 11/30/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 15 of 17

HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0142-2021
Recall number
D-0142-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1029202007, Exp 12/29/20

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 16 of 17

LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0143-2021
Recall number
D-0143-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1105202006, Exp 12/18/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

drug · product 17 of 17

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

D-0144-2021
Recall number
D-0144-2021
Initiated
November 30, 2020
Classification
Class II
Status
Ongoing
Quantity
1 vial

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: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Code information

Lot #1110202006, exp 12/10/2020

Distribution pattern

CA, CO, FL, IN, KY, OH, TX

Field note

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