Drugs | Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. | All Lots | Class II | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Compounding Centre At Blue Ridge |
Drugs | PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. | All Lots | Class II | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Compounding Centre At Blue Ridge |
Drugs | Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. | All Lots | Class II | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Compounding Centre At Blue Ridge |
Drugs | Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. | All Lots | Class II | Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. | Compounding Centre At Blue Ridge |
Drugs | Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607. | All Lots | Class II | Lack of Assurance of Sterility; All lots of sterile products compounded by
the pharmacy within expiry are subject to this recall. This recall is initiated
due to concerns associated with quality control procedures observed during a
recent FDA inspection. quoted from here |
WALTHAM, Mass.--(Village Fertility Pharmacy is conducting a voluntary recall of compounded medications shipped over the past three months. The recall resulted after particulate was discovered in a small percentage of two lots of Progesterone. Immediately upon learning of the situation, Village contacted the Massachusetts Board of Pharmacy.
)--“We are working cooperatively with all government agencies and are awaiting the results of the investigation”
After an initial investigation, Village and the Massachusetts Board of Pharmacy decided to expand the recall to include one other medication, Leuprolide. More testing is being conducted and results will be released in the coming days.
“We are working cooperatively with all government agencies and are awaiting the results of the investigation,” according to Stuart Levine, president of Village Fertility Pharmacy. “While no patients have reported any adverse effects, we believe the prudent course is to recall all of these medications.”
The recall includes:
- Progesterone Injection Cottonseed Oil 50 MG/ML
- Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML
- Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML
- Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML
- Hydroxy Progesterone Caproate 250 MG/ML
- Compounded Leuprolide Acetate 1MG/.2ML
Progesterone is a hormone that supports gestation. It is compounded in different solutions to accommodate patients’ various needs. Leuprolide suppresses natural ovulation.
Village Fertility Pharmacy is a pharmacist-owned and operated specialty fertility pharmacy dedicated to providing exceptional service and educational resources to fertility patients and clinics. Compounding represents five percent of the company’s total work.
Patients with questions can call the Village Recall Hotline at 1-888-965-5813.