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-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-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-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-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-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-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-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-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-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-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-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-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-0254-2020	08-12-2019	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 / 1x5ml 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-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-0208-2020	08-12-2019	S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 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-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-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-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-0287-2020	08-12-2019	S-TEST CYP/NAN-DECA 200/50MG/ML MDV 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 / 3x10 ml glass vials	Class II	Terminated
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
D-1836-2019	07-29-2019	Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00 Package NDCs: 0832-0285-00	Failed Dissolution Specifications	Upsher Smith Laboratories, Inc. / 166 bottles	Class II	Terminated
D-1842-2019	07-29-2019	Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 Package NDCs: 65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39	Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B	Aurobindo Pharma USA Inc. / 2,352/1000 count bottles	Class III	Terminated
D-1824-2019	07-26-2019	Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 927,108 bottles	Class II	Terminated
D-1831-2019	07-26-2019	Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 17,316 bottles	Class II	Terminated
D-1825-2019	07-26-2019	Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 1,872,984 bottles	Class II	Terminated
D-1829-2019	07-26-2019	Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 124,038 bottles	Class II	Terminated
D-1834-2019	07-26-2019	Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 1,030,128 bottles	Class II	Terminated
D-1833-2019	07-26-2019	Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 793,872 bottles	Class II	Terminated
D-1828-2019	07-26-2019	Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112106905.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 25,992 bottles	Class II	Terminated
D-1830-2019	07-26-2019	Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 1,752 bottles	Class II	Terminated
D-1827-2019	07-26-2019	Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112105434.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 66,168 bottles	Class II	Terminated
D-1823-2019	07-26-2019	Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 1,621,200 bottles	Class II	Terminated
D-1826-2019	07-26-2019	Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 20,808 bottles	Class II	Terminated
D-1835-2019	07-26-2019	Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591 A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 314,112 bottles	Class II	Terminated
D-1822-2019	07-26-2019	Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 6,661,188 bottles	Class II	Terminated
D-1832-2019	07-26-2019	Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.	CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.	Medtech Products, Inc. / 1,836 bottles	Class II	Terminated
D-0022-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0008-2020	07-24-2019	C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 60 nebulizer vials	Class II	Terminated
D-0007-2020	07-24-2019	C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0004-2020	07-24-2019	C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 droptainer bottle	Class II	Terminated
D-0010-2020	07-24-2019	C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 droptainer vial	Class II	Terminated
D-0003-2020	07-24-2019	C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 2 droptainer bottles	Class II	Terminated
D-0032-2020	07-24-2019	C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 droptainer bottle	Class II	Terminated
D-0011-2020	07-24-2019	C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0014-2020	07-24-2019	C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 18 vials	Class II	Terminated
D-0005-2020	07-24-2019	C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 12 droptainer bottles	Class II	Terminated
D-0026-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0027-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0031-2020	07-24-2019	C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0016-2020	07-24-2019	C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 6 syringes	Class II	Terminated
D-0017-2020	07-24-2019	C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 15 syringes	Class II	Terminated
D-0033-2020	07-24-2019	C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 7 vials	Class II	Terminated
D-0030-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0018-2020	07-24-2019	C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, and 3 mL syringes, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 191 syringes	Class II	Terminated
D-0006-2020	07-24-2019	C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 droptainer bottles	Class II	Terminated
D-0028-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0023-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0009-2020	07-24-2019	C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 37 vials	Class II	Terminated
D-0015-2020	07-24-2019	C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 droptainer bottle	Class II	Terminated
D-0025-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated
D-0012-2020	07-24-2019	C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 30 syringe	Class II	Terminated
D-0020-2020	07-24-2019	C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067	Lack of Assurance of Sterility: product sterility cannot be guaranteed.	Colonia Care Pharmacy / 1 vial	Class II	Terminated