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 October 09, 2026 and include a total of 18002 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
D-0277-2020	08-12-2019	S-MIC 25/50/50MG/ML CYANO 1MG/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 / 1x30 ml glass vial	Class II	Terminated
D-0291-2020	08-12-2019	S-TESTOSTERONE PROPIONATE 100MG/ML MDV 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 / 2x10 ml glass vials	Class II	Terminated
D-0271-2020	08-12-2019	S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 135x30 ml glass vials	Class II	Terminated
D-0227-2020	08-12-2019	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 / 2x5 ml vials	Class II	Terminated
D-0225-2020	08-12-2019	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 / 5x30 ML vials	Class II	Terminated
D-0220-2020	08-12-2019	S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 5x30 ml glass vials	Class II	Terminated
D-0278-2020	08-12-2019	S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30ml glass vials	Class II	Terminated
D-0201-2020	08-12-2019	S-ATROPINE 0.01% OPHTHALMIC SOLUTION, packaged in a) 10ml and b) 50 ml dropper bottle, Rx only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 6x10 ml, 1x50 ml dropper bottle	Class II	Terminated
D-0222-2020	08-12-2019	S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2 1L- bottles	Class II	Terminated
D-0243-2020	08-12-2019	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 / 3x10 ml glass vials	Class II	Terminated
D-0275-2020	08-12-2019	S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 108x 10 and 30 ml glass vials	Class II	Terminated
D-0241-2020	08-12-2019	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 / 24x30 ml vials	Class II	Terminated
D-0245-2020	08-12-2019	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 / 1x30 ml glass vial	Class II	Terminated
D-0281-2020	08-12-2019	S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x10ml glass vial	Class II	Terminated
D-0235-2020	08-12-2019	S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x1 ml syringe	Class II	Terminated
D-0249-2020	08-12-2019	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 / 3x10 ml glass vials	Class II	Terminated
D-0251-2020	08-12-2019	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 / 3x30 ml glass vials	Class II	Terminated
D-0204-2020	08-12-2019	S-B5/B6/B12M 100/50/10MG/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 / 5x10 ml glass vials	Class II	Terminated
D-0296-2020	08-12-2019	S-TRIMIX (29.4MG/0.98MG/9.8MCG/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 / 3x5ml glass vial	Class II	Terminated
D-0282-2020	08-12-2019	S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 91 x 5, 10, 13 ML glass vials	Class II	Terminated
D-0234-2020	08-12-2019	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 / 13x50 ml vials	Class II	Terminated
D-0217-2020	08-12-2019	S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x50ml, 6x100ml glass vials	Class II	Terminated
D-0255-2020	08-12-2019	S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml glass vials	Class II	Terminated
D-0233-2020	08-12-2019	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 / 1x2ML syringe	Class II	Terminated
D-0265-2020	08-12-2019	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 / 8x10 ML vials	Class II	Terminated
D-0219-2020	08-12-2019	S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x5ml, 1x10 ml glass vials	Class II	Terminated
D-0206-2020	08-12-2019	S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 glass vial	Class II	Terminated
D-0259-2020	08-12-2019	S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x50 ml plastic container	Class II	Terminated
D-0228-2020	08-12-2019	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 / N/A	Class II	Terminated
D-0247-2020	08-12-2019	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 / 38x30 ml glass vials	Class II	Terminated
D-0289-2020	08-12-2019	S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 ml glass vials	Class II	Terminated
D-0216-2020	08-12-2019	S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x10 ml glass vials	Class II	Terminated
D-0209-2020	08-12-2019	S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 5x10 ml and 5x30 ml glass vials	Class II	Terminated
D-0238-2020	08-12-2019	S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml vials	Class II	Terminated
D-0285-2020	08-12-2019	S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 559 x 5, 10, 13 ml glass vials	Class II	Terminated
D-0264-2020	08-12-2019	S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10, 1x30 ml glass vials	Class II	Terminated
D-0283-2020	08-12-2019	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 / 1x5 ml glass vial	Class II	Terminated
D-0246-2020	08-12-2019	S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10ml droptainer	Class II	Terminated
D-0292-2020	08-12-2019	S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 10x10 ml glass vial	Class II	Terminated
D-0293-2020	08-12-2019	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 / 46 x30 ML glass vials	Class II	Terminated
D-0273-2020	08-12-2019	S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 28x30 ml glass vials	Class II	Terminated
D-0261-2020	08-12-2019	S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 10 50 ml vials	Class II	Terminated
D-0263-2020	08-12-2019	S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2 5ml and 10 ml glass vials	Class II	Terminated
D-0230-2020	08-12-2019	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 / 2x30 glass vials	Class II	Terminated
D-0224-2020	08-12-2019	S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x12 ML and 79x30 ML vials	Class II	Terminated
D-0290-2020	08-12-2019	S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x 10ml and 13 ml glass vials	Class II	Terminated
D-0202-2020	08-12-2019	S-ATROPINE 0.02% OPTHALMIC SOLUTION, 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 / 2x10 ml dropper bottles	Class II	Terminated
D-0200-2020	08-12-2019	S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x 10 ml bottles	Class II	Terminated
D-0279-2020	08-12-2019	S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A	Class II	Terminated
D-0229-2020	08-12-2019	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 / 2x30 ml glass vials	Class II	Terminated
D-0284-2020	08-12-2019	S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE 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 / 1x5ml glass vial	Class II	Terminated
D-0242-2020	08-12-2019	S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10ml glass vial	Class II	Terminated
D-0295-2020	08-12-2019	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 / 1x5 ml glass vial	Class II	Terminated
D-0270-2020	08-12-2019	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 / 6 vials	Class II	Terminated
D-0231-2020	08-12-2019	S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5 ml vial	Class II	Terminated
D-0274-2020	08-12-2019	S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A	Class II	Terminated
D-0198-2020	08-12-2019	S-AMITRIPTYLINE 10MG/ML MDV INJ 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 / 2 x 30 mL vials	Class II	Terminated
D-0262-2020	08-12-2019	S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml, 7x10ml, 3x11ml, glass vials	Class II	Terminated
D-0203-2020	08-12-2019	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 / 1x10 ml dropper bottle	Class II	Terminated
D-0232-2020	08-12-2019	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 / 1x30 ml vial	Class II	Terminated
D-0253-2020	08-12-2019	S-TESTOSTERONE HALF ULTRA 125MG/ML MDV IN SESAME OIL (TEST CYP 100MG/TEST PROP 12.5MG/NANDROLONE DECA 12.5), Rx Only, 5ML glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml glass vial	Class II	Terminated
D-0297-2020	08-12-2019	S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 34x5ml glass vial	Class II	Terminated
D-0199-2020	08-12-2019	S-ASCORBIC ACID 500MG/ML MDV SOLN (NON-CORN), packaged in a) 50ML, b) 5ML, c) 30ML, glass vial, RX Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 81 vials	Class II	Terminated
D-0268-2020	08-12-2019	S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A	Class II	Terminated
D-0257-2020	08-12-2019	S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 16x5 and 10 ml glass vials	Class II	Terminated
D-0276-2020	08-12-2019	S-MIC 25/50/50 B12A 5MG/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 / 7x30 ml glass vials	Class II	Terminated
D-0286-2020	08-12-2019	S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 129x 5ml, 10ml, 13ml glass vials	Class II	Terminated
D-0280-2020	08-12-2019	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 / 1x5ml glass vial	Class II	Terminated
D-0267-2020	08-12-2019	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 / 1x30 Ml glass vial	Class II	Terminated
D-0214-2020	08-12-2019	S-DMSO 100% (PF) STERILE SOLUTION; packaged in a) 50 ml and b) 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 / 10x50m ml and 1x10 ml glass vials	Class II	Terminated
D-0269-2020	08-12-2019	S-HYDROXYPROG CAPROATE 250MG/ML OIL INJ, packaged in a) 5ML b) 10ML glass vial, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 16 5ml and 10ml glass vials	Class II	Terminated
D-0223-2020	08-12-2019	S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1, 3 ml prefilled syringe	Class II	Terminated
D-0248-2020	08-12-2019	S-QUADMIX (30MG/2MG/20MCG/0.15MG/ML) 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 / 2x5ml Glass vials	Class II	Terminated
D-0236-2020	08-12-2019	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 / 1x30 ML vial	Class II	Terminated
D-0252-2020	08-12-2019	S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 13x5 and 10 ml glass vials	Class II	Terminated
D-0218-2020	08-12-2019	S-ESTRADIOL CYP 5MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 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 / 11 5ml and 10ml glass vials	Class II	Terminated
D-0211-2020	08-12-2019	S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 37x30 ml glass vials	Class II	Terminated
D-0239-2020	08-12-2019	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 / 2x10 ml vials	Class II	Terminated
D-0237-2020	08-12-2019	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 / N/A	Class II	Terminated
D-0215-2020	08-12-2019	S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 glass vials	Class II	Terminated
D-0250-2020	08-12-2019	S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding Rx	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 11x10 ml glass vials	Class II	Terminated
D-0213-2020	08-12-2019	S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5 ml glass vial	Class II	Terminated
D-0221-2020	08-12-2019	S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1 5ml bottle	Class II	Terminated
D-0226-2020	08-12-2019	S-HCG 1200U/ML MDV INJ SOLN; packaged in a) 5 ML, b) 10 ML, c) 30 ML glass vial. Red Mountain Compounding RX	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 81 vials	Class II	Terminated
D-0244-2020	08-12-2019	S-POTASSIUM CHLORIDE 2 MEQ/ML INJECTION CONC (PF) 5ml glass vial, Rx Only Red Mountain Compounding Rx.	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml glass vial	Class II	Terminated
D-0260-2020	08-12-2019	S-DMSO 6.25% 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 / 7x10 ml dropper bottles	Class II	Terminated
D-0266-2020	08-12-2019	S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 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 / 11x 5ml and 10ml glass vials	Class II	Terminated
D-1821-2019	08-09-2019	Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11	Failed Dissolution Specifications	American Health Packaging / 457 cartons	Class II	Terminated
D-1859-2019	08-09-2019	Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-15), and c) 4 Oz (NDC 69804-073-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 109.64 ounces total	Class II	Terminated
D-1856-2019	08-09-2019	PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 383.65 ounces total	Class II	Terminated
D-1860-2019	08-09-2019	Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 136 ounces	Class II	Terminated
D-1857-2019	08-09-2019	PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 109.64 ounces total	Class II	Terminated
D-1858-2019	08-09-2019	Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), and c) 4 OZ (NDC 69804-070-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 383.65 ounces total	Class II	Terminated
D-1861-2019	08-09-2019	Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.	Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.	Ridge Properties, LLC / 104.1 ounces	Class II	Terminated
D-1846-2019	08-08-2019	Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01 Package NDCs: 65757-300-01; 65757-302-02; 65757-304-03; 65757-301-01; 65757-303-02; 65757-305-03	Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.	Alkermes Inc / 6,514 kits	Class II	Terminated
D-1743-2019	08-07-2019	Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17 Package NDCs: 68462-298-17; 68462-298-55	Temperature Abuse: Complaints received of liquidy texture.	Glenmark Pharmaceuticals Inc., USA / 31,224 tubes	Class III	Terminated
D-1841-2019	08-06-2019	Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.	Akorn, Inc. / 8187 vials	Class III	Terminated
D-1840-2019	08-06-2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.	Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.	Akorn, Inc. / 648 vials	Class III	Terminated
D-1839-2019	08-06-2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.	Akorn, Inc. / 4085 vials	Class III	Terminated
D-1030-2020	08-05-2019	Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).	Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.	RemedyRepack Inc. / 480 tablets	Class II	Terminated