The Recall Desk
ModerateFDA (Drugs)·D-1227-2020·Announced 2020-04-22

Betahistine 16 mg Capsules Recalled for Lack of Processing Control

The Medicine Shoppe Pharmacy is recalling Betahistine 16 mg capsules due to lack of processing control. The recall affects 2 bottles distributed in Florida.

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 situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is 'Lack of Processing Control,' which is a quality issue rather than a direct, high-risk contamination like a pathogen or allergen, 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 Betahistine 16 mg Capsules, 180 capsules per bottle. The recall is being conducted due to a lack of processing control. The affected product is prescription (Rx) medication.

The recall involves 2 bottles of the medication. The specific lot number is 45266, and the discard by date is 9/26/2020. The product was distributed in Florida.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
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 (1)

  • Lot: 45266 Discard by: 9/26/2020

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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