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-0714-2017 | 04-18-2017 | DMPS ACID *5ML* SDV 50MG/ML INJ, Injection, 50mg/ml, Rx only, 5 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 214 vials | Class II | Terminated |
| D-0737-2017 | 04-18-2017 | TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 200 vials | Class II | Terminated |
| D-0765-2017 | 04-18-2017 | GLUTATHIONE INH *PV* 200MG/ML SOLN, Inhalation Solution, 200mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 240 mL | Class II | Terminated |
| D-0763-2017 | 04-18-2017 | FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials total (2/5mL vials and 1/10mL) | Class II | Terminated |
| D-0744-2017 | 04-18-2017 | TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0711-2017 | 04-18-2017 | ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 60 mL total | Class II | Terminated |
| D-0721-2017 | 04-18-2017 | HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 50 vials | Class II | Terminated |
| D-0766-2017 | 04-18-2017 | GSH/NAC INH 2ML PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL, Rx only, 5mL Plastic/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 50 mL | Class II | Terminated |
| D-0709-2017 | 04-18-2017 | 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0730-2017 | 04-18-2017 | PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 4 vials | Class II | Terminated |
| D-0740-2017 | 04-18-2017 | TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ, Injection, 13mcg/30mg/0.8mg/mL, RX only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0729-2017 | 04-18-2017 | PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 4 vials | Class II | Terminated |
| D-0716-2017 | 04-18-2017 | FERR GLUC/PROCAINE 10ML MDV 60/10MG/ML INJ, Injection, 60mg/10mg/mL, Rx only, 10 mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0748-2017 | 04-18-2017 | TRI MIX 40/30/4 5ML MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 5 vials | Class II | Terminated |
| D-0745-2017 | 04-18-2017 | TRI MIX 20/30/2 5ML MDV MCG/MG/MG/1ML INJ, Injection, 20mcg/30mg/2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial , Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 17 vials | Class II | Terminated |
| D-0962-2017 | 04-18-2017 | Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0968-2017 | 04-18-2017 | BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0784-2017 | 04-18-2017 | VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0746-2017 | 04-18-2017 | TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0751-2017 | 04-18-2017 | TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 4 vials | Class II | Terminated |
| D-0772-2017 | 04-18-2017 | PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 40 vials | Class II | Terminated |
| D-0753-2017 | 04-18-2017 | TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0733-2017 | 04-18-2017 | PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0719-2017 | 04-18-2017 | FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 12 vials total (3/2mL vials and 9/10mL vias) | Class II | Terminated |
| D-0736-2017 | 04-18-2017 | TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0718-2017 | 04-18-2017 | FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials total | Class II | Terminated |
| D-0781-2017 | 04-18-2017 | SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 91 vials | Class II | Terminated |
| D-0774-2017 | 04-18-2017 | PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 9 vials total (3/10mL vials and 6/50mL vials) | Class II | Terminated |
| D-0757-2017 | 04-18-2017 | PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 4 vials | Class II | Terminated |
| D-0741-2017 | 04-18-2017 | TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0724-2017 | 04-18-2017 | HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial. | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 8 vials total (6/10mL vials and 2/30 mL vials) | Class II | Terminated |
| D-0755-2017 | 04-18-2017 | QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0712-2017 | 04-18-2017 | ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 9 mL | Class II | Terminated |
| D-0775-2017 | 04-18-2017 | PROGESTERONE SESAME OIL 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass; Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0752-2017 | 04-18-2017 | TRI MIX 5/30/0.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0777-2017 | 04-18-2017 | PYRIDOXAL-5-PHOS 5ML MDV 50MG/ML INJ, 50mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 3 vials | Class II | Terminated |
| D-0734-2017 | 04-18-2017 | PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0770-2017 | 04-18-2017 | METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 25 vials | Class II | Terminated |
| D-0966-2017 | 04-18-2017 | TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0971-2017 | 04-18-2017 | LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0961-2017 | 04-18-2017 | UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260 | Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin | Organic Herbal Supply / | Class I | Terminated |
| D-0758-2017 | 04-18-2017 | ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0727-2017 | 04-18-2017 | HYDROXO-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, packaged in a 5 mL and 30 mL Glass/ Multiple Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 27 vials total (25/5 mL vials and 2/30mL vials) | Class II | Terminated |
| D-0767-2017 | 04-18-2017 | GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 180mL | Class II | Terminated |
| D-0783-2017 | 04-18-2017 | TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 6 vials total (5/5mL vials and 1/10mL vial) | Class II | Terminated |
| D-0710-2017 | 04-18-2017 | 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial) | Class II | Terminated |
| D-0761-2017 | 04-18-2017 | CYANOCOBALAMIN 10ML MDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0739-2017 | 04-18-2017 | TRI MIX 11.8/17.6/0.59 5ML MDV MCG/MG/MG/ML INJ, Injection, 11.8mcg/17.6mg/0.59mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 1 vial | Class II | Terminated |
| D-0715-2017 | 04-18-2017 | DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 10 mL total | Class II | Terminated |
| D-0726-2017 | 04-18-2017 | HYDROXO-B12 30ML PBF MDV (CALIF) 1MG/ML INJ, Injection, 1mg/mL, Rx only, 30 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0735-2017 | 04-18-2017 | TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. | Key Pharmacy and Compounding Center / 2 vials | Class II | Terminated |
| D-0695-2017 | 04-17-2017 | Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5. | Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container. | Fagron, Inc / | Class III | Terminated |
| D-0377-2019 | 04-17-2017 | EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01 | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Syntho Pharmaceuticals, Inc. / 5,000 bottles | Class II | Terminated |
| D-0378-2019 | 04-17-2017 | EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01 | CGMP deviations: Lots were recalled due to sub-potency and cGMP violations. | Syntho Pharmaceuticals, Inc. / 5,000 bottles | Class II | Terminated |
| D-0919-2017 | 04-17-2017 | ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327 | cGMP Deviations; lack of quality assurance. | American Pharmaceutical Ingredients LLC / 1g=1 bottle; 5g=4 bottle; 25g=3 bottles | Class II | Terminated |
| D-0694-2017 | 04-17-2017 | Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3. | Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point. | P & L Development, LLC / 369,012 cartons | Class III | Terminated |
| D-0881-2017 | 04-13-2017 | Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435. | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection. | Spectrum Laboratory Products, Inc. / 48 containers | Class II | Terminated |
| D-0882-2017 | 04-13-2017 | Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229. | CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection. | Spectrum Laboratory Products, Inc. / 1 container | Class II | Terminated |
| D-0864-2017 | 04-13-2017 | Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4. | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. | Standard Homeopathic Company / 692,115 bottles | Class I | Terminated |
| D-0863-2017 | 04-13-2017 | Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061. | Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. | Standard Homeopathic Company / 10,263,585 bottles | Class I | Terminated |
| D-0787-2017 | 04-07-2017 | Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15 | Superpotent Drug | Teligent, Inc. / 3600 tubes | Class III | Terminated |
| D-0686-2017 | 04-06-2017 | Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,156 vials | Class II | Terminated |
| D-0681-2017 | 04-06-2017 | Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 4,001 vials | Class II | Terminated |
| D-1166-2017 | 04-06-2017 | Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52 | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product. | PharMedium Services, Llc / 295 bags | Class II | Terminated |
| D-0685-2017 | 04-06-2017 | Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 851 vials | Class II | Terminated |
| D-0791-2017 | 04-06-2017 | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 15283 grams | Class II | Terminated |
| D-0792-2017 | 04-06-2017 | Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547 | cGMP Deviations: lack of quality assurance at the API manufacturer. | Fagron, Inc / 1313 grams | Class II | Terminated |
| D-0684-2017 | 04-06-2017 | Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 1,951 vials | Class II | Terminated |
| D-1165-2017 | 04-06-2017 | Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52. | Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product. | PharMedium Services, Llc / 590 bags | Class II | Terminated |
| D-0687-2017 | 04-06-2017 | Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 5,165 bottles | Class II | Terminated |
| D-0682-2017 | 04-06-2017 | Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,352 vials | Class II | Terminated |
| D-0683-2017 | 04-06-2017 | Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1. | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. | Isomeric Pharmacy Solution, LLC / 2,335 vials | Class II | Terminated |
| D-0651-2017 | 04-04-2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19 | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print. | West-Ward Columbus, Inc. / 100 bottles | Class III | Terminated |
| D-0665-2017 | 04-03-2017 | ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g (NDC 38779-0869-06), c) 5 g (NDC 38779-0869-03), d) 10 g (NDC 38779-0869-01), e) 25 g (NDC 38779-0869-04), f) 100 g (NDC 38779-0869-05) , g) 500 g (NDC 38779-0869-08), h) 1 Kg (NDC 38779-0869-09) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0869 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0664-2017 | 04-03-2017 | ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0666-2017 | 04-03-2017 | ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g (NDC 38779-2261-05) bottles, Packed by MEDISCA INC. PLATTSBURGH, NY Product Code 2261 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-0865-2017 | 04-03-2017 | Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ | Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel. | Cell Distributors / 2,634 bottles (58 bottles/5mL & 2576 bottles/15 mL) | Class II | Terminated |
| D-0663-2017 | 04-03-2017 | ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams (NDC 38779-0732-04) , c) 100 grams (NDC 38779-0732-05), and d) 1 Kg (NDC 38779-0732-09) bottles, Packed by MEDISCA, INC. PLATTSBURGH, NY 12901; Product Code 0732 | cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection | Medisca, Inc. / N/A | Class II | Terminated |
| D-1051-2017 | 03-30-2017 | Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 56,064 36-count cartons | Class II | Terminated |
| D-1044-2017 | 03-30-2017 | Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 1,067,520 12-count cartons | Class II | Terminated |
| D-1050-2017 | 03-30-2017 | Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048 | Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. | Bayer HealthCare Pharmaceuticals, Inc. / 24,672 24-count cartons | Class II | Terminated |
| D-0677-2017 | 03-28-2017 | hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO | Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug | Gary Wood / 1305-1400 bottles | Class II | Terminated |
| D-0676-2017 | 03-28-2017 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532 Package NDCs: 51672-1272-1; 51672-1272-2; 51672-1272-3; 51672-1263-1; 51672-1263-2; 51672-1263-3 | Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability | Taro Pharmaceuticals U.S.A., Inc. / 278,304 tubes | Class II | Terminated |
| D-0703-2017 | 03-28-2017 | PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87 | Failed Stability Specifications | Teva Pharmaceuticals USA / 49,089 bottles | Class III | Terminated |
| D-0867-2017 | 03-28-2017 | LaBri's Body Health Atomic, 60 capsules | Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine. | Envy Me / unknown | Class I | Terminated |
| D-0659-2017 | 03-24-2017 | Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0657-2017 | 03-24-2017 | Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0655-2017 | 03-24-2017 | Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0654-2017 | 03-24-2017 | Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0656-2017 | 03-24-2017 | Estriol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China 44132-007-06 | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0660-2017 | 03-24-2017 | Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01), | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0658-2017 | 03-24-2017 | Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06) | cGMP Deviations; lack of quality assurance. | Qinhuangdao Zizhu Pharmaceutical, Co. / N/A | Class II | Terminated |
| D-0702-2017 | 03-22-2017 | Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 14,784 bottles | Class III | Terminated |
| D-0701-2017 | 03-22-2017 | Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 38,316 bottles | Class III | Terminated |
| D-0626-2017 | 03-22-2017 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20. Package NDCs: 0173-0682-20; 0173-0682-24 | Defective Delivery System: Elevated number of units with out of specification results for leak rate. | GlaxoSmithKline, LLC / 593,088 inhalers | Class II | Ongoing |
| D-0679-2017 | 03-22-2017 | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15 Package NDCs: 61314-203-15; 61314-204-15; 61314-206-15 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corp. / N/A | Class III | Terminated |
| D-0700-2017 | 03-22-2017 | Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 6,138 bottles | Class III | Terminated |
| D-0699-2017 | 03-22-2017 | Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). | Sun Pharmaceutical Industries, Inc. / 60 bottles | Class III | Terminated |
| D-0678-2017 | 03-22-2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15 | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corp. / N/A | Class III | Terminated |
| D-0622-2017 | 03-21-2017 | Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20 Package NDCs: 51079-208-01; 51079-208-20; 51079-209-01; 51079-209-20; 51079-210-01; 51079-210-20; 51079-211-01; 51079-211-03 | Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,527 cartons | Class II | Terminated |
