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-1646-2019 | 06-19-2019 | DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1692-2019 | 06-19-2019 | PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0136-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1649-2019 | 06-19-2019 | DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0904-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1712-2019 | 06-19-2019 | TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0193-81 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1666-2019 | 06-19-2019 | HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0949-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1636-2019 | 06-19-2019 | Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0975-50 | Crystallization | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1707-2019 | 06-19-2019 | STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 10 ML vial: 70731-0188-10; NDC 30 ML vial: 70731-0188-30; NDC 50 ML vial: 70731-0188-50 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1705-2019 | 06-19-2019 | LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0919-01 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1702-2019 | 06-19-2019 | ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0238-55 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1639-2019 | 06-19-2019 | BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0139-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1710-2019 | 06-19-2019 | THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0950-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1700-2019 | 06-19-2019 | PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0955-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1647-2019 | 06-19-2019 | DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0969-89 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1680-2019 | 06-19-2019 | MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0100-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1667-2019 | 06-19-2019 | HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0926-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1663-2019 | 06-19-2019 | GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0906-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1644-2019 | 06-19-2019 | CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0946-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1648-2019 | 06-19-2019 | diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0929-02 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1668-2019 | 06-19-2019 | Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0999-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1714-2019 | 06-19-2019 | TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0206-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1687-2019 | 06-19-2019 | MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0973-81 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1686-2019 | 06-19-2019 | MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0138-89 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1660-2019 | 06-19-2019 | FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0921-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1638-2019 | 06-19-2019 | BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30ML NDC: 70731-0137-30] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0137-03 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1706-2019 | 06-19-2019 | SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0905-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1642-2019 | 06-19-2019 | CALCIUM GLUCONATE 5% INJECTION SOLUTION (MDV), 20 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0903-20 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1654-2019 | 06-19-2019 | Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0934-11 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1694-2019 | 06-19-2019 | POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0954-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1671-2019 | 06-19-2019 | LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0174-20 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1683-2019 | 06-19-2019 | MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-55 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1685-2019 | 06-19-2019 | MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0964-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1640-2019 | 06-19-2019 | BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0139-84 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1650-2019 | 06-19-2019 | EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0934-11 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1682-2019 | 06-19-2019 | MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-86 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1655-2019 | 06-19-2019 | EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0201-85 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1643-2019 | 06-19-2019 | Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0925-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1641-2019 | 06-19-2019 | CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0920-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1674-2019 | 06-19-2019 | MAGNESIUM CHLORIDE HEXAHYDRATE (MDV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0977-50 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1695-2019 | 06-19-2019 | PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0109-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1672-2019 | 06-19-2019 | LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0172-20 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1698-2019 | 06-19-2019 | PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0970-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1699-2019 | 06-19-2019 | PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0956-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1677-2019 | 06-19-2019 | METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0130-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1670-2019 | 06-19-2019 | KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC: 70731-0132-05] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1658-2019 | 06-19-2019 | fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0118-55 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1664-2019 | 06-19-2019 | HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0907-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1684-2019 | 06-19-2019 | MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0917-01 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1656-2019 | 06-19-2019 | EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0113-22 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1673-2019 | 06-19-2019 | MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0176-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1690-2019 | 06-19-2019 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0157-20 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1688-2019 | 06-19-2019 | NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0143-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1634-2019 | 06-19-2019 | Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10 | Crystallization | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1711-2019 | 06-19-2019 | TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0151-50 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1675-2019 | 06-19-2019 | MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0951-50 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1665-2019 | 06-19-2019 | HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89; b) 55 ML NDC 70731-0114-95] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1697-2019 | 06-19-2019 | PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0900-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1715-2019 | 06-19-2019 | TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dropper bottle, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0205-05 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1691-2019 | 06-19-2019 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0158-02 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1701-2019 | 06-19-2019 | RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0923-02 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1708-2019 | 06-19-2019 | SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0129-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1693-2019 | 06-19-2019 | PHO-TID-CHOL 50MG/ DEOXYCHOLIC 42 MG/ML INJ, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0953-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1651-2019 | 06-19-2019 | EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0931-11 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1709-2019 | 06-19-2019 | TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0958-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1661-2019 | 06-19-2019 | FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0924-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1645-2019 | 06-19-2019 | DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0932-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1669-2019 | 06-19-2019 | KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0173-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1637-2019 | 06-19-2019 | Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-0197-92; c) 0.15 mL NDC 70731-0197-93] per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1635-2019 | 06-19-2019 | Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0914-65 | Crystallization | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1678-2019 | 06-19-2019 | METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0915-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1662-2019 | 06-19-2019 | GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0971-81 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1703-2019 | 06-19-2019 | RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0918-01 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1689-2019 | 06-19-2019 | NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0938-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1696-2019 | 06-19-2019 | PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0987-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1653-2019 | 06-19-2019 | EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0922-11 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1681-2019 | 06-19-2019 | MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0978-30 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1676-2019 | 06-19-2019 | MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0952-10 | Lack of Assurance of Sterility | RXQ Compounding LLC / N/A | Class II | Terminated |
| D-1425-2019 | 06-18-2019 | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 125 dropper bottles | Class II | Terminated |
| D-1426-2019 | 06-18-2019 | Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 13150 vials | Class II | Terminated |
| D-1413-2019 | 06-18-2019 | ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 824 vials | Class II | Terminated |
| D-1414-2019 | 06-18-2019 | Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 86 syringes | Class II | Terminated |
| D-1420-2019 | 06-18-2019 | Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 1834 irrigation vials | Class II | Terminated |
| D-1419-2019 | 06-18-2019 | Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 323 vials | Class II | Terminated |
| D-1417-2019 | 06-18-2019 | Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 1235 bags | Class II | Terminated |
| D-1427-2019 | 06-18-2019 | SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 6423 syringes | Class II | Terminated |
| D-1424-2019 | 06-18-2019 | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 1040 syringes | Class II | Terminated |
| D-1415-2019 | 06-18-2019 | Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 2315 syringes | Class II | Terminated |
| D-1423-2019 | 06-18-2019 | Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 4363 syringes | Class II | Terminated |
| D-1418-2019 | 06-18-2019 | Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 40 bags | Class II | Terminated |
| D-1422-2019 | 06-18-2019 | Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 4806 syringes | Class II | Terminated |
| D-1412-2019 | 06-18-2019 | Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 578 vials | Class II | Terminated |
| D-1428-2019 | 06-18-2019 | SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 1721 syringes | Class II | Terminated |
| D-1411-2019 | 06-18-2019 | Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 745 syringes | Class II | Terminated |
| D-1421-2019 | 06-18-2019 | Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 6 vials | Class II | Terminated |
| D-1416-2019 | 06-18-2019 | Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7. | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance. | Premier Pharmacy Labs Inc / 606 bags | Class II | Terminated |
| D-1396-2019 | 06-17-2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07. Package NDCs: 24208-503-07; 24208-503-48; 24208-503-96 | Failed Stability Specifications: Out of specification for viscosity. | Bausch & Lomb / 170832 bottles | Class III | Terminated |
| D-1463-2019 | 06-14-2019 | Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / 14,955 bottles (1,345,950 tablets) | Class II | Terminated |
| D-1464-2019 | 06-14-2019 | Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / 1,470 bottles (1,470,000 tablets) | Class II | Terminated |
| D-1465-2019 | 06-14-2019 | Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / 32,835 bottles (2,955,150 tablets) | Class II | Terminated |
| D-1462-2019 | 06-14-2019 | Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. | Golden State Medical Supply Inc. / 4,037 bottles (121,110 tablets) | Class II | Terminated |
| D-1343-2019 | 06-13-2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20. Package NDCs: 0264-9567-10; 0264-9577-10; 0264-9587-20 | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications. | B. Braun Medical Inc / 40,176 bags | Class II | Terminated |
