Naltrexone Suspension Recalled for Lack of Processing Control
The Medicine Shoppe Pharmacy is recalling Naltrexone 4.5 mg/mL Suspension due to lack of processing control. The product was distributed in Florida.
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, but the source text does not report any hospitalizations or significant injuries, aligning with the 'Moderate' severity criteria for minor or low-risk issues.
Plain-English summary
The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Naltrexone 4.5 mg/mL Suspension, 30 mL bottles. The recall was initiated due to a lack of processing control. The affected product is prescription-only and was distributed in Florida.
The specific lot number is 45177, with a discard-by date of September 4, 2020. The U.S. Food and Drug Administration 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.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for instructions on disposal or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
- Manufacturer
- The Medicine Shoppe Pharmacy
- Category
- Drug — Pharmacy Compounded
- 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: 45177 Discard by: 9/4/2020
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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