Reliable Drug Recalls Potassium Bromide Products Due to Processing Control Issues
Reliable Drug is recalling all compounded potassium bromide products due to a lack of processing controls. The recall affects products distributed in California, Hawaii, and New Mexico.
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 and involves a lack of processing controls without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Reliable Drug/Reliable Compounding Pharmacy is recalling all potassium bromide products that are prescription-only and compounded by the company. The recall is being conducted due to a lack of processing controls. The affected products were compounded between March 24, 2015, and March 24, 2016, and are within their expiration dates.
The recalled products were distributed in the United States, specifically in California, Hawaii, and New Mexico. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- All potassium bromide 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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