Avella of Deer Valley, Inc. Store 38

FDA Regulatory Profile

Summary

Total Recalls
50
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0152-2020Class IIPovidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty PharmSeptember 18, 2019
D-1308-2019Class IIBevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA SPECIALTY PHARMACY 24416May 3, 2019
D-0999-2019Class IIMAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by AveFebruary 8, 2019
D-0997-2019Class IILabetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. RepackFebruary 8, 2019
D-1000-2019Class IIMAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella SpeciFebruary 8, 2019
D-0998-2019Class IIMAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by AvelFebruary 8, 2019
D-0224-2019Class IIBEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) RepackOctober 31, 2018
D-0133-2019Class IIHydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, October 19, 2018
D-0131-2019Class IIMorphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and AveOctober 19, 2018
D-0135-2019Class IIPhenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, October 19, 2018
D-0134-2019Class IIPhenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, October 19, 2018
D-0132-2019Class IIFentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of October 19, 2018
D-0943-2018Class IIePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mJune 12, 2018
D-0960-2018Class IINORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (ConcJune 12, 2018
D-0930-2018Class IIePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQJune 12, 2018
D-0941-2018Class IIVancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) VoluJune 12, 2018
D-0939-2018Class IINORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (CJune 12, 2018
D-0932-2018Class IIEPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of June 12, 2018
D-0956-2018Class IIMidazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL.June 12, 2018
D-0935-2018Class IIHYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 5June 12, 2018