BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0132-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0131-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0141-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0134-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0140-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0142-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0128-2021December 23, 2020Indianapolis, IN
CIPLA
Class IITerminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Inde...
Reason: cGMP deviations: Vials may not be sealed correctly affecting sterility.
D-0165-2021December 23, 2020Warren, NJ
Advanced Nutriceuticals, LLC
Class IIOngoing
NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0136-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0143-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0137-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0135-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0129-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0130-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0133-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0139-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0144-2021December 23, 2020Indianapolis, IN
Advanced Nutriceuticals, LLC
Class IIOngoing
DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
D-0138-2021December 23, 2020Indianapolis, IN
CareFusion 213, LLC
Class ITerminated
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subs...
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
D-1509-2020August 26, 2020El Paso, TX
CareFusion 213, LLC
Class ITerminated
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of...
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
D-1510-2020August 26, 2020El Paso, TX
CareFusion 213, LLC
Class ITerminated
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC ...
Reason: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
D-1511-2020August 26, 2020El Paso, TX
Pfizer Inc.
Class IITerminated
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12
Reason: Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
D-1446-2020August 12, 2020New York, NY
EMD Serono, Inc.
Class IITerminated
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
Reason: Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
D-1379-2020July 15, 2020Rockland, MA
BIOTA Biosciences LLC
Class IITerminated
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
D-1328-2020July 1, 2020Seattle, WA
BIOTA Biosciences LLC
Class IITerminated
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
Reason: Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin