DrugMay 8, 2019
Advanced Pharma HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% recall — FDA D-1251-2019
Sub-potency
Class IIFDA: TerminatedAdvanced Pharma Inc.
Recall history in this database
Classification mix: Class II: 16, Class I: 4, Class III: 3.
DrugMar 27, 2019
Advanced Pharma Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate recall — FDA D-1033-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1023-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1022-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1028-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable recall — FDA D-1020-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution recall — FDA D-1016-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1034-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugFeb 27, 2019
Advanced Pharma Oxytocin 20 Units added to NS 1000 mL recall — FDA D-0498-2019
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class IIIFDA: TerminatedAdvanced Pharma Inc.
DrugFeb 27, 2019
Advanced Pharma Oxytocin 30 Units added to NS 500 mL recall — FDA D-0499-2019
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class IIIFDA: TerminatedAdvanced Pharma Inc.
DrugFeb 27, 2019
Advanced Pharma Oxytocin 10 Units added to NS 1000 mL recall — FDA D-0497-2019
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class IIIFDA: TerminatedAdvanced Pharma Inc.
DrugFeb 27, 2019
Advanced Pharma Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL recall — FDA D-0496-2019
Labeling: Incorrect expiration date.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugJan 30, 2019
Advanced Pharma HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% recall — FDA D-0430-2019
Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as 50 Units/50 mL (1 Unit/mL)
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugJan 2, 2019
Advanced Pharma Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable recall — FDA D-0347-2019
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Class IFDA: TerminatedAdvanced Pharma Inc.
DrugJul 4, 2018
Advanced Pharma fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL recall — FDA D-0889-2018
Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin recall — FDA D-0119-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL recall — FDA D-0114-2018
Subpotent Drug: found to be below the specification for labeled assay.
Class IFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL recall — FDA D-0117-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL) recall — FDA D-0116-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin recall — FDA D-0115-2018
Subpotent Drug: found to be below the specification for labeled assay.
Class IFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL recall — FDA D-0118-2018
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugDec 27, 2017
Advanced Pharma NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL) recall — FDA D-0113-2018
Subpotent Drug: found to be below the specification for labeled assay.
Class IFDA: TerminatedAdvanced Pharma Inc.
DrugJul 19, 2017
Advanced Pharma QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial recall — FDA D-0953-2017
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Advanced Pharma Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.