Class II · Moderate risk
Glycerin 100% PF
Lack of Assurance of Sterility
FDA Drug Recalls
5,405 recalls, newest first
Class II · Moderate risk
Dexamethasone Sodium Phosphate 4 mg/mL vials PF
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine 100 mcg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Sodium Phosphate 6 mg/mL P Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone…
Lack of Assurance of Sterility
Class I · High risk
Methylprednisolone Acetate 80 mg/mL Injection
Non-Sterility
Class I · High risk
Methylprednisolone Acetate 40 mg/mL Injection
Non-Sterility
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class II · Moderate risk
Cymevene 500 mg Powder for Infusion
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Preservative-Free MORPHINE Sulfate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Class II · Moderate risk
I-C Drops
Lack of Assurance of Sterility: The product is being recalled because the product label does not state sterile in accordance with 21 CFR Part 200.50(a)(1), Ophthalmic Preparations and Dispensers, and it is not in compliance with 21 CFR Part 349, Ophthalmic Drug Products for Over-The-Counter Use.
Class II · Moderate risk
CMS-2374-R4 Custom US Breast Core Biopsy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
CMS-8934 Custom Phlebectomy Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags.
Class II · Moderate risk
Custom Access Tray
Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags
Class II · Moderate risk
Indocyanine Green - Kit 15mg Injectable 1 Kit
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hypertonic Solution in Preserved Water 10% Injectable 50 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/Ml Injectable 10 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydroxocobalamin**
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydromorphone/Clonidine P. F. 120mg/1.3mcg/Ml Intrathecal 10 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydromorphone/Baclofen/Bupivacaine
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydromorphone P.F. 20mg/Ml Intrathecal 40 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Hydrogen Peroxide Pf 3% Injectable 150 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.