Multi-event November 2020 FDA Recall Drug by Advanced Nutriceuticals, Llc

This Multi-event Class II drug recall was voluntarily initiated by Advanced Nutriceuticals, Llc on November 30, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in CA, CO, FL, IN, KY, OH, TX and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-0133-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
4 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

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

Recall Number: D-0139-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1110202004 Exp 12/10/2020

Recall Number: D-0130-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1112202006, Exp 12/12/2020

Recall Number: D-0134-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

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

Recall Number: D-0132-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
4 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration 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

Recall Number: D-0140-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

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

Recall Number: D-0128-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
6 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration 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

Recall Number: D-0141-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1030202010, Exp 11/30/2020

Recall Number: D-0131-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
3 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

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

Recall Number: D-0142-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1029202007, Exp 12/29/20

Recall Number: D-0129-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1112202006, Exp 12/12/2020

Recall Number: D-0135-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1112202008, Exp 12/11/2020

Recall Number: D-0144-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1110202006, exp 12/10/2020

Recall Number: D-0138-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1111202002, Exp 12/11/2020

Recall Number: D-0143-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1105202006, Exp 12/18/2020

Recall Number: D-0137-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
1 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

Lot# 1111202001, Exp 01/11/2021

Recall Number: D-0136-2021

Reason for Recall
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Initiated
11-30-2020
Reported
12-23-2020
Quantity
2 vials

Recall Profile & Regulatory Data

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Advanced Nutriceuticals, LLC
CA, CO, FL, IN, KY, OH, TX
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Batch or Lot Expiration Information

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