FDA Recalls Estradiol, Progesterone, and Testosterone Cream Due to Processing Control Issues
The FDA is recalling Estradiol/Progesterone/Testosterone cream from The Medicine Shoppe Pharmacy in Florida due to a lack of processing control.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any illnesses or injuries, and the hazard is related to processing control rather than a specific high-risk pathogen or structural defect, fitting the Moderate criteria for a precautionary or minor labeling/processing error.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream, 30 gm tube, manufactured by The Medicine Shoppe Pharmacy in Port Charlotte, Florida. The recall is classified as Class II and is attributed to a lack of processing control.
The affected product is a prescription cream distributed in Florida. The specific lot number is 44560, with a discard-by date of 03/24/2020. The source text does not specify the exact nature of the processing control failure or report any illnesses or injuries associated with the product.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed. The recall is limited to the specific lot identified in the notice.
The recalled product
- Product
- Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
- Manufacturer
- The Medicine Shoppe Pharmacy
- Hazard
- Affected units
- 1
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)
- Lot: 44560 Discard by: 03/24/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 54 recalled by The Medicine Shoppe 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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