FDA Recalls Bi-Est Cream Due to Lack of Processing Control
The FDA is recalling Bi-Est cream from The Medicine Shoppe Pharmacy in Florida due to a 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, which typically involves a situation that may cause temporary or medically reversible health consequences. The specific reason, 'Lack of Processing Control,' suggests a quality issue rather than a confirmed high-risk pathogen or severe injury, fitting the Moderate severity criteria for voluntary or precautionary quality recalls.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL. The product is a prescription cream manufactured by The Medicine Shoppe Pharmacy in Port Charlotte, Florida.
The recall was initiated due to a lack of processing control. The affected product is identified by Lot 45148 with a discard by date of 8/30/2020. The distribution pattern is limited to Florida.
Consumers who have this product should contact their healthcare provider or the pharmacy for further instructions on how to dispose of the medication.
The recalled product
- Product
- Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, 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: 45148 Discard by: 8/30/2020
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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