Paregoric Compound Solution Recalled for Lack of Processing Control
The Medicine Shoppe Pharmacy in Port Charlotte, FL, is recalling Paregoric Compound Solution 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, and the source text does not report any illnesses, injuries, or specific contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Medicine Shoppe Pharmacy in Port Charlotte, Florida, is recalling Paregoric Compound (contains Morphine) Solution, 480 mL bottles. The recall is being conducted due to a lack of processing control.
The affected product is prescription (Rx) medication. The specific lot number is 45161, and the discard-by date is May 4, 2020. The product was distributed in Florida.
Consumers with this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Paregoric Compound (contains Morphine) Solution 480 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: 45161 Discard by: 5/4/2020
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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