Sildenafil 80 mg capsules recalled for expired components and labeling errors
MPRX, Inc. dba Medical Park Pharmacy is recalling Sildenafil 80 mg capsules compounded with expired components and incorrect labeling.
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 adverse health consequences. The hazard involves labeling errors and the use of expired components, which fits the criteria for a moderate severity recall without reported serious injuries or deaths.
Plain-English summary
MPRX, Inc. dba Medical Park Pharmacy is recalling Sildenafil 80 mg capsules. The recall is due to labeling errors, specifically incorrect or missing lot and expiration dates, and the use of expired components in the compounding process.
The affected product is identified by Lot 61404:42 with a use-by date of 05/06/2020. The distribution pattern is listed as TX, indicating the product was distributed in Texas.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Sildenafil 80 mg capsules
- Manufacturer
- MPRX, Inc. dba Medical Park Pharmacy
- Category
- Drug — Compounded Medication
- 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: 61404:42 Use by: 05/06/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 18 recalled by MPRX, Inc. dba Medical Park 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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