Reliable Drug Recalls Fluoxymesterone Products Due to Processing Control Deficiencies
Reliable Drug is recalling all fluoxymesterone products compounded between March 2015 and March 2016 due to a lack of processing controls.
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 due to a lack of processing controls, which fits the rubric for moderate severity involving potential but not confirmed serious harm.
Plain-English summary
Reliable Drug/Reliable Compounding Pharmacy is recalling all fluoxymesterone products, which are prescription-only medications. The recall is being conducted because of a lack of processing controls during the compounding process.
The affected products were compounded between March 24, 2015, and March 24, 2016, and must be within their expiration dates. The distribution pattern includes the United States, specifically California, Hawaii, and New Mexico.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- All fluoxymesterone 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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