US Compounding Inc

FDA Regulatory Profile

Summary

Total Recalls
65 (1 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0223-2021Class IIISuccinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1December 16, 2020
D-0175-2021Class IIINeostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only. US November 25, 2020
D-0508-2019Class IIEphedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don'January 29, 2019
D-0482-2019Class IILET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe,January 24, 2019
D-0219-2017Class IDocusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), July 25, 2016
D-0286-2016Class IITriamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only,September 12, 2015
D-0253-2016Class IIGlycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, CompoundSeptember 12, 2015
D-0237-2016Class IIAlprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial, Rx only, Compounded by US CompoundinSeptember 12, 2015
D-0285-2016Class IITriamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, CSeptember 12, 2015
D-0283-2016Class IITrace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese September 12, 2015
D-0273-2016Class IIPhenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral Injection, Rx only, CompounSeptember 12, 2015
D-0293-2016Class IIVoriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, CompSeptember 12, 2015
D-0243-2016Class IIBrompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding PhaSeptember 12, 2015
D-0270-2016Class IIMorphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by USeptember 12, 2015
D-0269-2016Class IIMIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding September 12, 2015
D-0262-2016Class IILincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection or IV Injection After DSeptember 12, 2015
D-0277-2016Class IIPhenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical OphthalmicSeptember 12, 2015
D-0260-2016Class IIL-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by September 12, 2015
D-0247-2016Class IIDapiprazole (Diluent+Powder) 0.5% in 5 mL vial, For topical ophthalmic use, Rx only, Compounded by September 12, 2015
D-0249-2016Class IIDex Combo (Dexamethasone acetate 8mg/mL, dexamethasone sodium phosphate USP, 4 mg/mL),30 mL Multi-DoSeptember 12, 2015