The Recall Desk
ModerateFDA (Drugs)·D-1199-2020·Announced 2020-04-22

Bi-Est Cream Recalled for Lack of Processing Control

The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progesterone/Testosterone cream 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 does not report any specific injuries, illnesses, or fatalities, and the hazard is described generally as a lack of processing control without specific pathogen or allergen identification.

Plain-English summary

The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tubes. The recall is being conducted due to a lack of processing control. The affected product is a prescription cream distributed in Florida.

The recall involves two tubes with the following lot numbers and discard-by dates: Lot 45023 (Discard by 7/27/2020) and Lot 45268 (Discard by 9/27/2020). The source text does not specify the exact nature of the processing control failure or any specific health risks associated with the product.

Consumers who have purchased this product should contact their healthcare provider or the pharmacy for further instructions on how to proceed. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
Manufacturer
The Medicine Shoppe Pharmacy
Category
Drug — Compounded Prescription Cream
Hazard
Affected units
2

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 (2)

  • Lot: 45023 Discard by: 7/27/2020
  • 45268 Discard by: 9/27/2020

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 →

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