| Apr 26, 2019 |
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% ... |
Sub-potency |
Class II |
| Mar 13, 2019 |
Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Ster... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable S... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q... |
Lack of Assurance of Sterility |
Class II |
| Mar 13, 2019 |
Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3... |
Lack of Assurance of Sterility |
Class II |
| Feb 6, 2019 |
Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of... |
Labeling: Incorrect expiration date. |
Class II |
| Feb 6, 2019 |
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... |
Superpotent Drug: product may contain concentrations of oxytocin higher than ... |
Class III |
| Feb 6, 2019 |
Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Inje... |
Superpotent Drug: product may contain concentrations of oxytocin higher than ... |
Class III |
| Feb 6, 2019 |
Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Inj... |
Superpotent Drug: product may contain concentrations of oxytocin higher than ... |
Class III |
| Jan 15, 2019 |
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodiu... |
Labeling; Label Error on Declared Strength; label incorrectly states the conc... |
Class II |
| Nov 29, 2018 |
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable So... |
Labeling: Label Error on Declared Strength: Label incorrectly lists concentra... |
Class I |
| Jun 20, 2018 |
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... |
Subpotent Drug: final drug concentration is subpotent as compared to the conc... |
Class II |
| Jan 5, 2018 |
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (US... |
Subpotent |
Class I |
| Jun 22, 2017 |
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS ... |
Lack of Assurance of Sterility |
Class II |
| Jun 22, 2017 |
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS ... |
Lack of Assurance of Sterility |
Class II |
| Jun 22, 2017 |
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS ... |
Lack of Assurance of Sterility |
Class II |
| Jun 22, 2017 |
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (... |
Lack of Assurance of Sterility |
Class II |
| Jun 9, 2017 |
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... |
Subpotent Drug: found to be below the specification for labeled assay. |
Class I |
| Jun 9, 2017 |
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... |
Stability Data Does Not Support Expiry: lots do not have stability that suppo... |
Class II |
| Jun 9, 2017 |
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... |
Subpotent Drug: found to be below the specification for labeled assay. |
Class I |
| Jun 9, 2017 |
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10... |
Stability Data Does Not Support Expiry: lots do not have stability that suppo... |
Class II |
| Jun 9, 2017 |
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Steri... |
Stability Data Does Not Support Expiry: lots do not have stability that suppo... |
Class II |
| Jun 9, 2017 |
NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per m... |
Subpotent Drug: found to be below the specification for labeled assay. |
Class I |
| Jun 9, 2017 |
NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 1... |
Stability Data Does Not Support Expiry: lots do not have stability that suppo... |
Class II |
| Feb 22, 2017 |
Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella ... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, ... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, A... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Av... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Av... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, ... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avell... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only,... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |
| Feb 22, 2017 |
Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packag... |
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/... |
Class II |