The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1192-2020·Announced 2020-04-22

Bi-Est 1:1 Cream Recalled for Lack of Processing Control

The Medicine Shoppe Pharmacy is recalling Bi-Est 1:1/Progesterone/Testosterone cream due to lack of processing control.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the reason 'Lack of Processing Control' suggests a quality issue without explicit reports of serious injury or death, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tubes. The recall is due to a lack of processing control.

The affected product is prescription (Rx) cream, specifically Lot 45108 with a discard by date of 8/18/2020. The product was distributed in Florida.

Consumers should stop using the product and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
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: 45108 Discard by: 8/18/2020

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 →

Same manufacturer · The Medicine Shoppe Pharmacy

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