Advanced Pharma Inc.

FDA Regulatory Profile

Summary

Total Recalls
99 (5 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Known Names

advanced pharmaceutical technology, advanced pharma

Recent Recalls

NumberClassProductDate
D-1251-2019Class IIHYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL,April 26, 2019
D-1021-2019Class IIGlycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852March 13, 2019
D-1020-2019Class IIPhenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcMarch 13, 2019
D-1022-2019Class IIPhenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mMarch 13, 2019
D-1033-2019Class IIMorphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium ChloriMarch 13, 2019
D-1023-2019Class IIPhenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg peMarch 13, 2019
D-1034-2019Class IIPhenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (March 13, 2019
D-1030-2019Class IIHeparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mLMarch 13, 2019
D-1029-2019Class IIEsmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile single use syringe, NDC: 428March 13, 2019
D-1016-2019Class IIHYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mLMarch 13, 2019
D-1025-2019Class IIGlycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, ForMarch 13, 2019
D-1032-2019Class IIPhenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable Solution 1 mg/10 mL (100March 13, 2019
D-1027-2019Class II2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDMarch 13, 2019
D-1024-2019Class IINeostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe,March 13, 2019
D-1031-2019Class IIHeparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium ChloridMarch 13, 2019
D-1018-2019Class IIfentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use March 13, 2019
D-1028-2019Class IIPhenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 March 13, 2019
D-1019-2019Class IIMidazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium ChloriMarch 13, 2019
D-1017-2019Class IIfentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile singMarch 13, 2019
D-1026-2019Class II2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDCMarch 13, 2019