Anderson Compounding Pharmacy Recalls Estradiol Cypionate Vials for Sterility Concerns
Anderson Compounding Pharmacy is recalling 35 vials of Estradiol Cypionate 10 mg/mL due to a lack of sterility assurance. The product was distributed nationwide.
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 is classified as FDA Class II. The hazard is a lack of sterility assurance, which poses a risk of harm (infection) but the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Anderson Compounding Pharmacy, Inc. is recalling 35 vials of Estradiol Cypionate 10 mg/mL, 5 mL Vial. The recall was initiated because of a lack of sterility assurance in the product. The affected product was distributed nationwide.
The recall covers all lots of the product. The source text does not specify a particular date range for the distribution or the recall initiation.
Consumers who have this product should contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 35
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 (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson 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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