Reliable Drug Recalls Compounded Malarone Products Due to Processing Controls
Reliable Drug is recalling compounded Malarone products due to a lack of processing controls. The recall covers all lots compounded between March 24, 2015, and March 24, 2016.
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 corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Reliable Drug, a compounding pharmacy located in San Francisco, California, is recalling all compounded Malarone (atovaquone and proguanil) products. The recall is being conducted due to a lack of processing controls. The affected products are prescription-only and were compounded by Reliable Drug/Reliable Compounding Pharmacy.
The recall includes all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates. The products were distributed in the United States, specifically in California, Hawaii, and New Mexico.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The FDA 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.
The recalled product
- Product
- All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Manufacturer
- Reliable Rexall-A Compounding Pharmacy
- Category
- Drug — Compounded Prescription
- Hazard
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)
- All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..
Distribution
Part of a larger recall action
This product is one of 70 recalled by Reliable Rexall-A Compounding 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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