| Sep 18, 2019 |
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... |
Lack of sterility assurance. |
Class II |
| May 3, 2019 |
Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S... |
Lack of assurance of sterility |
Class II |
| Feb 8, 2019 |
MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use ... |
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain... |
Class II |
| Feb 8, 2019 |
MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use b... |
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain... |
Class II |
| Feb 8, 2019 |
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL sin... |
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain... |
Class II |
| Feb 8, 2019 |
MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Com... |
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain... |
Class II |
| Oct 31, 2018 |
BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n... |
Lack of Assurance of Sterility |
Class II |
| Oct 19, 2018 |
Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/... |
Lack of assurance of sterility |
Class II |
| Oct 19, 2018 |
Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma... |
Lack of assurance of sterility |
Class II |
| Oct 19, 2018 |
Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... |
Lack of assurance of sterility |
Class II |
| Oct 19, 2018 |
Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Ave... |
Lack of assurance of sterility |
Class II |
| Oct 19, 2018 |
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... |
Lack of assurance of sterility |
Class II |
| Jun 12, 2018 |
EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL sing... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chlor... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (U... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropiva... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodiu... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chlorid... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacai... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (U... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 1... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 m... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL sing... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP)... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chlorid... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL)... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chlorid... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% De... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dex... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextros... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (U... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 ... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Sin... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |
| Jun 12, 2018 |
0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP Q... |
Lack of Assurance of Sterility: Potential leakage of bags. |
Class II |