Well Care Compounding Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns
Well Care Compounding Pharmacy is recalling Testosterone Cypionate 10mg/mL vials because FDA inspections found GMP violations that may affect sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Testosterone Cypionate 10mg/mL, packaged in 5mL vials. The product is prescription-only and was distributed in Nevada.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The source text does not report any illnesses or injuries associated with the use of these vials.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable Steroids
- 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 #: 02032016: 60@27
- Exp. 05/03/2016
- Lot #: 02222016: 29@62
- Exp. 05/22/2016
- Lot #: 03072016:87@66
- Exp.06/06/2016
- Lot #: 4152016:34@39
- Exp. 07/18/2016
- Lot #: 04282016:06@14
- Exp. 07/27/2016.
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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