Naltrexone Capsules Recalled for Lack of Processing Control
The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg capsules 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 indicates a temporary or medically reversible adverse health consequence. The specific hazard is a lack of processing control, which is a quality issue rather than a direct, high-risk contamination or structural defect.
Plain-English summary
The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Naltrexone (Loxoral) 4.5 mg capsules. The product is sold in 60-count prescription bottles. The specific lot number is 44898, and the discard-by date is March 23, 2020.
The recall was initiated due to a lack of processing control. This issue may affect the quality or consistency of the medication.
Consumers who have this specific lot of Naltrexone capsules should stop using them and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
- Manufacturer
- The Medicine Shoppe Pharmacy
- Category
- Drug — Prescription Medication
- 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: 44898 Discard by: 3/23/2020
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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