Home / Recalls / Advanced Nutriceuticals, LLC / D-0136-2021

D-0136-2021 Class II Ongoing

Recalled by Advanced Nutriceuticals, LLC — Indianapolis, IN

FDA drug recall D-0136-2021 was initiated by Advanced Nutriceuticals, LLC on November 30, 2020 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. The recall status is ongoing. Affected quantity: 2 vials.

Recall Details

Product Type
Drugs
Report Date
December 23, 2020
Initiation Date
November 30, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 vials

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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

Other recalls by Advanced Nutriceuticals, LLC

  • D-0133-2021 Class II — THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicin (November 30, 2020)
  • D-0142-2021 Class II — HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, (November 30, 2020)
  • D-0130-2021 Class II — PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianap (November 30, 2020)
  • D-0134-2021 Class II — IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, I (November 30, 2020)
  • D-0140-2021 Class II — THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medi (November 30, 2020)
  • D-0141-2021 Class II — GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianap (November 30, 2020)
  • D-0132-2021 Class II — BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indi (November 30, 2020)
  • D-0128-2021 Class II — CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Ind (November 30, 2020)
  • D-0131-2021 Class II — AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indi (November 30, 2020)
  • D-0129-2021 Class II — FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapoli (November 30, 2020)

FDA data resources