Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 150mg/mL vials because FDA inspections found GMP violations that may affect sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which aligns with the criteria for Severe severity due to potential for serious injury.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling Testosterone Cypionate 150mg/mL, packaged in 5mL vials. The recall involves 869 units distributed in Nevada.
The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. This lack of assurance of sterility poses a risk to patients using the medication.
Patients who have received this product should contact their healthcare provider or pharmacist for guidance on next steps. The recalled lots include specific expiration dates and lot numbers listed in the official recall notice.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot #: 01042016:26@3
- Exp.04/03/2016
- Lot #: 01072016: 10@15
- Exp.04/06/2016
- Lot #: 02032016:41@16
- Exp. 05/03/2016
- Lot #: 03152016: 62@44
- Exp.06/15/2016
- Lot #: 04292016:35@11
- Exp. 07/31/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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