Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0103-2023 | 12-30-2022 | QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 78 vials | Class II | Terminated |
| D-0126-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0097-2023 | 12-29-2022 | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA, Package NDCs: 0409-7620-13; 0409-7620-03; 0409-7620-49; 0409-7620-59; 0409-1005-01; 0409-1005-20; 0409-2222-01; 0409-2222-12 | Lack of assurance of sterility: Bags have the potential to leak. | Pfizer Inc. / 62,088 bags | Class II | Completed |
| D-0159-2023 | 12-28-2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 Package NDCs: 67877-259-30; 67877-260-30 | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. | Ascend Laboratories, LLC / 12192 bottles | Class II | Terminated |
| D-0095-2023 | 12-28-2022 | Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20 Package NDCs: 55150-154-10; 55150-155-20 | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial | Eugia US LLC / 45,250 vials | Class II | Ongoing |
| D-0280-2023 | 12-27-2022 | CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 71 bags total | Class II | Terminated |
| D-0296-2023 | 12-27-2022 | HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50 | Lack of sterility assurance | Sentara Infusion Services / 37 bags | Class II | Terminated |
| D-0321-2023 | 12-27-2022 | TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 24 bags | Class II | Terminated |
| D-0284-2023 | 12-27-2022 | D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 2 | Class II | Terminated |
| D-0317-2023 | 12-27-2022 | TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 2 bags | Class II | Terminated |
| D-0281-2023 | 12-27-2022 | CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 3 bags | Class II | Terminated |
| D-0311-2023 | 12-27-2022 | NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 31 syringes | Class II | Terminated |
| D-0312-2023 | 12-27-2022 | ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 15 bags | Class II | Terminated |
| D-0283-2023 | 12-27-2022 | CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 72 bags | Class II | Terminated |
| D-0300-2023 | 12-27-2022 | Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 25 bags | Class II | Terminated |
| D-0288-2023 | 12-27-2022 | Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 1 bag | Class II | Terminated |
| D-0306-2023 | 12-27-2022 | METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 30 bags | Class II | Terminated |
| D-0318-2023 | 12-27-2022 | TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 26 bags | Class II | Terminated |
| D-0277-2023 | 12-27-2022 | CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0289-2023 | 12-27-2022 | Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 15 bags | Class II | Terminated |
| D-0309-2023 | 12-27-2022 | MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 5 bags | Class II | Terminated |
| D-0286-2023 | 12-27-2022 | DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 bags | Class II | Terminated |
| D-0316-2023 | 12-27-2022 | Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 11 bags | Class II | Terminated |
| D-0319-2023 | 12-27-2022 | TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ; 255GM/DEX ; 50GM/LIP 3500 ml, (i) 90GM/AA ; 255GMDEX 3500 ml, (j) TPN AA 100GM DEX: 320GM LIP: 50GM 2400ML, (k) TPN AA 30GM DEX: 145GM 1210ML, (l) TPN AA 30GM DEX: 145GM LIP: 35GM 1210ML, (m)TPN AA 42GM DEX: 432GM 2070ML, (n) TPN AA 50GM DEX: 130GM 2500ML, (o) TPN AA 55GM DEX:180GM 1000ML, (p) TPN AA 70GM DEX:290GM 2100ML, (q) TPN AA 70GM DEX:290GM 2500ML, (r) TPN AA 80GM DEX:200GM 1900ML, (s) TPN AA 80GM DEX:200GM LIP:38GM 1900ML, (t) TPN AA 30GM ; DEX 82GM ; IN 890 ml, (u) TPN AA 30GM ; DEX 82GM ; LIP 18GM IN 890 ml, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 111 bags | Class II | Terminated |
| D-0305-2023 | 12-27-2022 | Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 27 syringes | Class II | Terminated |
| D-0328-2023 | 12-27-2022 | BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11 Package NDCs: 60687-340-11; 60687-340-01; 60687-351-11; 60687-351-01 | Failed Impurities/Degradation Specifications | Amerisource Health Services LLC / 1,416 cartons | Class II | Terminated |
| D-0096-2023 | 12-27-2022 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06 Package NDCs: 59746-113-06; 59746-113-10; 59746-115-06; 59746-115-10 | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. | Jubilant Cadista Pharmaceuticals, Inc. / 14,061 bottles | Class III | Terminated |
| D-0313-2023 | 12-27-2022 | PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0293-2023 | 12-27-2022 | FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 13 bags | Class II | Terminated |
| D-0323-2023 | 12-27-2022 | VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 18 bags | Class II | Terminated |
| D-0279-2023 | 12-27-2022 | CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 syringes | Class II | Terminated |
| D-0308-2023 | 12-27-2022 | MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 11 bags | Class II | Terminated |
| D-0304-2023 | 12-27-2022 | METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 19 syringes | Class II | Terminated |
| D-0320-2023 | 12-27-2022 | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 31 bags | Class II | Terminated |
| D-0310-2023 | 12-27-2022 | NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 16 bags | Class II | Terminated |
| D-0295-2023 | 12-27-2022 | HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04 | Lack of sterility assurance | Sentara Infusion Services / 32 syringes | Class II | Terminated |
| D-0291-2023 | 12-27-2022 | Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 22 bags | Class II | Terminated |
| D-0314-2023 | 12-27-2022 | PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 bags | Class II | Terminated |
| D-0303-2023 | 12-27-2022 | MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 91 bags | Class II | Terminated |
| D-0324-2023 | 12-27-2022 | VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 1 bag | Class II | Terminated |
| D-0307-2023 | 12-27-2022 | Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN 0.45% NS 65ML, (k) 56MG IN 0.45% NS 70ML, (l) 68MG IN 0.45% NS 85ML, (m) 84MG IN 0.45% NS 105ML, (n) 88MG IN 0.45% NS 110ML, (o) 92MG IN 0.45% NS 115ML, (p) 96MG IN 0.45% NS 120ML, ionotrop, Rx Only, use with a Curlin or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 83 bags | Class II | Terminated |
| D-0294-2023 | 12-27-2022 | GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 5 bags | Class II | Terminated |
| D-0274-2023 | 12-27-2022 | AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 19 bags | Class II | Terminated |
| D-0272-2023 | 12-27-2022 | 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 114 bags total | Class II | Terminated |
| D-0290-2023 | 12-27-2022 | DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 4 | Class II | Terminated |
| D-0285-2023 | 12-27-2022 | D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 bags | Class II | Terminated |
| D-0278-2023 | 12-27-2022 | CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 111 bags total 21 syringes total | Class II | Terminated |
| D-0275-2023 | 12-27-2022 | AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0282-2023 | 12-27-2022 | CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / bags | Class II | Terminated |
| D-0301-2023 | 12-27-2022 | Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0297-2023 | 12-27-2022 | IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25 | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0292-2023 | 12-27-2022 | ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 syringes | Class II | Terminated |
| D-0287-2023 | 12-27-2022 | DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 bags | Class II | Terminated |
| D-0315-2023 | 12-27-2022 | PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 78 bags | Class II | Terminated |
| D-0322-2023 | 12-27-2022 | Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 155 bags | Class II | Terminated |
| D-0298-2023 | 12-27-2022 | INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0302-2023 | 12-27-2022 | LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 7 syringes | Class II | Terminated |
| D-0299-2023 | 12-27-2022 | KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 14 syringes | Class II | Terminated |
| D-0276-2023 | 12-27-2022 | Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 20 bags | Class II | Terminated |
| D-0273-2023 | 12-27-2022 | Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0247-2023 | 12-23-2022 | Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 75381 packets | Class I | Terminated |
| D-0245-2023 | 12-23-2022 | Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 2016 packets | Class I | Terminated |
| D-0252-2023 | 12-23-2022 | CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 15000 packets | Class I | Terminated |
| D-0244-2023 | 12-23-2022 | Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 2880 packets | Class I | Terminated |
| D-0249-2023 | 12-23-2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 194460 packets | Class I | Terminated |
| D-0253-2023 | 12-23-2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 7200 packets | Class I | Terminated |
| D-0251-2023 | 12-23-2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 8280 packets | Class I | Terminated |
| D-0248-2023 | 12-23-2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 37464 packets | Class I | Terminated |
| D-0250-2023 | 12-23-2022 | Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 66400 packets | Class I | Terminated |
| D-0246-2023 | 12-23-2022 | Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213 | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis. | GFA Production Xiamen Co. Ltd. / 60048 packets | Class I | Terminated |
| D-0208-2023 | 12-22-2022 | FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0188-2023 | 12-22-2022 | Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 5MG/ML (1ML vial) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0200-2023 | 12-22-2022 | Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0217-2023 | 12-22-2022 | LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0239-2023 | 12-22-2022 | THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0235-2023 | 12-22-2022 | SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0212-2023 | 12-22-2022 | GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0190-2023 | 12-22-2022 | 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0242-2023 | 12-22-2022 | VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0222-2023 | 12-22-2022 | METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 25MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0192-2023 | 12-22-2022 | Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0225-2023 | 12-22-2022 | NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0232-2023 | 12-22-2022 | POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0237-2023 | 12-22-2022 | TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0229-2023 | 12-22-2022 | PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0206-2023 | 12-22-2022 | ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 5MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0226-2023 | 12-22-2022 | PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0203-2023 | 12-22-2022 | Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0187-2023 | 12-22-2022 | Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0214-2023 | 12-22-2022 | HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0218-2023 | 12-22-2022 | LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0234-2023 | 12-22-2022 | PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1 60MCG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0238-2023 | 12-22-2022 | TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP/PROP(80/20)-GS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-CS OIL-PF- 80MG/ML (0.7ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 100MG/ML (1.2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 300MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL-PF- 75MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-OLIVE OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 125MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL-PF- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE ENAN-GS OIL-PF- 300MG/ML (0.4ML VIAL) INJECTABLE TESTOSTERONE-PF- 50MG/ML (5%) (1ML DROPTAINERS) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0199-2023 | 12-22-2022 | Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0227-2023 | 12-22-2022 | PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0191-2023 | 12-22-2022 | Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0240-2023 | 12-22-2022 | TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0209-2023 | 12-22-2022 | GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0194-2023 | 12-22-2022 | Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0241-2023 | 12-22-2022 | VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
