Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2

Most recent recall enforcement reports first.
Class	Reported	Product	Reason	Firm	Status
Class II	November 13, 2019	S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-LEVOCARNITINE 100MG/ML MDV INJ SOLN, 30ML vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class III	November 13, 2019	Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets,…	Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.	Sato Pharmaceutical Inc.	Terminated
Class II	November 13, 2019	S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) MDV INJ, Rx Only, 5ml Glass vial. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 10 ml glass vials, Rx…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-LYSINE HCL 100MG/ML MDV, 30ML vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10 ml, glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg,…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TAURINE 50MG/ML MDV SOLN, Rx only 30ml glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-B5/B6/B12M 100/50/10MG/ML MDV SOLN, 30ML glass vial, RX only, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle,…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL)…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz.…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MIC 25/50/50MG/ML CYANO 1MG/ML MDV SOLN, RX Only, 30ml glass vial, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials.…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 ml glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg,…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg,…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class I	November 13, 2019	LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake…	Presence of Particulate Matter.	ICU Medical Inc	Terminated
Class II	November 13, 2019	S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class I	November 13, 2019	0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake…	Presence of Particulate Matter.	ICU Medical Inc	Terminated
Class II	November 13, 2019	Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl.…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL)…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class I	November 13, 2019	Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules,…	Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved…	Green Lumber Holdings, LLC	Terminated
Class II	November 13, 2019	S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial,…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan…	Presence of Foreign Substance	Mylan Pharmaceuticals Inc.	Terminated
Class II	November 13, 2019	S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial,…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively…	Marketed without an Approved NDA/ANDA	Basic Reset Inc.	Terminated
Class II	November 13, 2019	S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class II	November 13, 2019	S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20;…	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy	Terminated
Class III	November 13, 2019	Cefdinir Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC…	Presence of Foreign substance: identified as a dead ant.	Lupin Pharmaceuticals Inc.	Terminated
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class III	November 13, 2019	Cefdinir Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for:…	Presence of Foreign substance: identified as a dead ant.	Lupin Pharmaceuticals Inc.	Terminated
Class II	November 13, 2019	Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Hydrochloride Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.)…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Hydrochloride Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.)…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count…	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class II	November 13, 2019	Ranitidine Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)	CGMP Deviations: Presence of NDMA impurity detected in product.	Dr. Reddy's Laboratories, Inc.	Completed
Class I	November 6, 2019	Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz…	Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.	FITOTERAPIA USA, INC	Terminated
Class III	November 6, 2019	Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100…	CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.	AuroMedics Pharma LLC	Ongoing
Class III	November 6, 2019	PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose…	Incorrect labeling: Incorrect or missing lot and/or exp date	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	November 6, 2019	AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC…	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	AVKARE Inc.	Terminated
Class II	November 6, 2019	AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC…	CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API	AVKARE Inc.	Terminated
Class II	November 6, 2019	Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only,…	Lack of Sterility Assurance.	Innoveix Pharmaceuticals Inc	Terminated
Class II	November 6, 2019	Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix…	Lack of Sterility Assurance.	Innoveix Pharmaceuticals Inc	Terminated
Class II	November 6, 2019	Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded…	Lack of Sterility Assurance.	Innoveix Pharmaceuticals Inc	Terminated
Class II	November 6, 2019	Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only,…	Lack of Sterility Assurance.	Innoveix Pharmaceuticals Inc	Terminated
Class II	November 6, 2019	Prasugrel Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan…	Failed Dissolution Specification: Low out of specification dissolution results.	Mylan Pharmaceuticals Inc.	Terminated
Class II	November 6, 2019	Ibuprofen Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free,…	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material…	Taro Pharmaceuticals U.S.A., Inc.	Terminated
Class III	November 6, 2019	Bimatoprost Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper…	Labeling: Incorrect or missing package insert.	Sandoz Inc	Terminated
Class II	November 6, 2019	Ibuprofen Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free,…	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material…	Taro Pharmaceuticals U.S.A., Inc.	Terminated
Class II	November 6, 2019	Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free,…	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material…	Taro Pharmaceuticals U.S.A., Inc.	Terminated
Class III	November 6, 2019	testosterone cypionate Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only,…	Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials,…	Arbor Pharmaceuticals Inc.	Terminated
Class II	November 6, 2019	ESTRADIOL VAGINAL INSERTS Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with…	Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.	Glenmark Pharmaceuticals Inc., USA	Terminated
Class II	November 6, 2019	Ibuprofen Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured…	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material…	Taro Pharmaceuticals U.S.A., Inc.	Terminated
Class II	November 6, 2019	Ibuprofen Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by:…	Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material…	Taro Pharmaceuticals U.S.A., Inc.	Terminated
Class III	November 6, 2019	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL…	Labeling: Incorrect or missing package insert.	Sandoz Inc	Terminated
Class III	November 6, 2019	Neomycin and Polymyxin B Sulfates and Dexamethasone Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only,…	Labeling: Incorrect or missing package insert.	Sandoz Inc	Terminated
Class III	November 6, 2019	ATORVASTATIN CALCIUM Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by:…	Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40…	Apotex Inc.	Terminated
Class II	October 30, 2019	Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella…	Lack of sterility assurance.	Avella of Deer Valley, Inc. Store 38	Terminated
Class II	October 30, 2019	del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B…	Lack of Assurance of Sterility; bags have potential to leak	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	October 30, 2019	Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl,…	Lack of Assurance of Sterility; bags have potential to leak	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	October 30, 2019	PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride…	GMP Deviations: potential glass contamination	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	October 30, 2019	PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride…	GMP Deviations: potential glass contamination	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	October 30, 2019	PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride…	GMP Deviations: potential glass contamination	Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center	Terminated
Class II	October 23, 2019	Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx…	CGMP Deviation: Presence of dark brown discoloration on edges of tablets.	Jubilant Cadista Pharmaceuticals, Inc.	Terminated
Class III	October 23, 2019	Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free…	Presence of Foreign Substance; Fiber particles.	KVK-Tech, Inc.	Terminated
Class II	October 23, 2019	Pioglitazone Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured…	Superpotent	Macleods Pharma Usa Inc	Terminated
Class II	October 23, 2019	Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC…	Crystallization: Presence of particulate matter identified as API crystallization	Ingenus Pharmaceuticals Llc	Terminated
Class II	October 23, 2019	Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx…	Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.	Atlas Pharmaceuticals, LLC	Terminated
Class II	October 23, 2019	Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP.,…	CGMP Deviations: Received notice from supplier that there is potential glass contamination.	Spectrum Laboratory Products	Terminated
Class II	October 23, 2019	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and…	Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.	Aurobindo Pharma USA Inc.	Terminated
Class III	October 16, 2019	Sodium Chloride Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe…	Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will…	GUERBET LLC	Terminated
Class II	October 16, 2019	Optiray Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 -…	Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will…	GUERBET LLC	Terminated
Class II	October 16, 2019	DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a)…	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.…	Unipharma, Llc.	Terminated
Class II	October 16, 2019	DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured…	CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B.…	Unipharma, Llc.	Terminated
Class II	October 16, 2019	Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle,…	Microbial Contamination of Non-Sterile Product.	GCP Laboratories Inc	Terminated
Class II	October 16, 2019	Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL)…	Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14	Morton Grove Pharmaceuticals, Inc.	Terminated
Class II	October 16, 2019	Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz…	CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).	Sandoz, Inc	Terminated
Class II	October 16, 2019	Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by…	CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).	Sandoz, Inc	Terminated
Class II	October 16, 2019	Estradiol Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC…	Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.	Epic Pharma, LLC	Terminated
Class II	October 16, 2019	Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz…	CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).	Sandoz, Inc	Terminated
Class III	October 16, 2019	Benazepril Hydrochloride Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal…	Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle	Amneal Pharmaceuticals, Inc.	Terminated
Class II	October 16, 2019	10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx…	Lack of Assurance of Sterility: Bag has the potential to leak.	Pfizer Inc.	Terminated
Class II	October 16, 2019	Rifampin Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional…	Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could…	Mylan Laboratories Limited (Sterile Products Division)	Terminated
Class III	October 16, 2019	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx…	GMP Deviation: lot not intended for commercial distribution.	Teva Pharmaceuticals USA	Terminated
Class II	October 9, 2019	Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only,…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF)…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only,…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy,…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only,…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy,…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for:…	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product…	Torrent Pharma Inc.	Ongoing
Class II	October 9, 2019	SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) /…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) /…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only,…	CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product…	Torrent Pharma Inc.	Ongoing
Class II	October 9, 2019	Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL)…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial, Rx only,…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10…	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc	Terminated
Class II	October 9, 2019	C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy,…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated
Class II	October 9, 2019	C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia…	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy	Terminated