FDA Recalls Estriol/Testosterone Vaginal Cream Due to Processing Control Issues
The FDA is recalling Estriol/Testosterone Vaginal 0.1/0.1% 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 indicates a temporary or medically reversible adverse health consequence. The source text cites 'Lack of Processing Control' without reporting specific illnesses or injuries, aligning with the criteria for a moderate severity score involving potential but unconfirmed risks or minor labeling/processing errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estriol/Testosterone Vaginal 0.1/0.1% Cream, 30 gm jar, 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 identified by Lot 45221 with a discard-by date of 9/12/2020. Distribution was limited to Florida. The source text does not specify the exact nature of the processing control failure or report any specific illnesses or injuries associated with the product.
Consumers who have this product should contact their healthcare provider or The Medicine Shoppe Pharmacy for further instructions on how to proceed. The FDA advises patients to stop using the product until further notice.
The recalled product
- Product
- Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
- Manufacturer
- The Medicine Shoppe Pharmacy
- Category
- Drug — Topical Steroid/Hormone
- 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: 45221 Discard by: 9/12/2020
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.
See all 54 products in this recall →Related recalls
Same manufacturer · The Medicine Shoppe Pharmacy
See all →- SevereBi-Est Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateDiethylstilbestrol Capsules Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateHydrocortisone Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateTestosterone Gel Recalled by Florida Pharmacy for Lack of Processing Control
FDA (Drugs) · 2020-04-22
- ModerateParegoric Alternate Elixir Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22
Same hazard · processing control
See all →- ModerateErgotamine Tartrate and Caffeine Suppositories Recalled for Processing Control Issues
FDA (Drugs) · 2020-04-22
- ModerateEstradiol Vaginal Cream Recalled for Lack of Processing Control
FDA (Drugs) · 2020-04-22