Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207 877-666-5222, NDC 52533-019-12 | Class II | Lot #: 9906, 9915 BUD: 7/28/2017; 9950, 9984, 10001,10010, BUD: 8/4/2017; 10064, BUD: 8/17/2017; 10341, 10452 BUD: 9/23/2017, | Lack of Sterility Assurance. | Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207-4144 |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, August 31, 2017
Recall of Veterinary Drug
CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle, Antiparasitic. Sterile. Contains 10 mg moxidectin/mL (5,000 mg/500 mL). Contents 500 mL. Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 USA | Class II | Lot AH01VL1, Product Code 81449783, Expiry Date 31/12/2018 | Lack of sterility assurance: Due to potential for bottles to leak. | Bayer Health Care LLC 12707 Shawnee Mission Pkwy Shawnee, KS 66216-1846 |
Recall of sterile compounded animal drugs
CYCLOSPORIN (VET) *CORN OIL* 1% Ophthalmic solution, 1%, RX only, 15mL Plastic/Multiple Dose vial | Class II | Lot 01-30-2017@2, Expiry date 4/30/2017 | The firm is recalling sterile compounded animal drug within expiry due to lack of assurance of sterility. | Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center 530 S 336th St Federal Way, WA 98003-6383 |
FDA observed vermin and a dead spider in a compounding pharmacy in Texas
"Vermin was observed present in areas immediately adjacent to your production area.
A dead spider was observed in HEPA filter located in the ceiling of the ISO 7 clean room, approximately 10 feet
from the ISO 5 laminar air flow (LAF) hood used for sterile drug processing."
See FDA 483
See FDA 483
Wednesday, August 30, 2017
Fentanyl drives another record year of Ohio overdose deaths
ABC News-7 hours ago
Compounding the problem was the appearance of drugs like carfentanil, an opioid so powerful it's used to sedate elephants, and the lacing of drugs like cocaine ...
07/20/2017 | 3011123993 | Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy | 483 | FL | Producer of Sterile Drug Products | 08/29/2017 |
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