Reliable Drug Recalls Compounded Sucralfate Products Due to Processing Controls
Reliable Drug is recalling all compounded sucralfate products due to a lack of processing controls. The recall covers 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, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Reliable Drug, a compounding pharmacy located in San Francisco, California, is recalling all sucralfate 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 between March 24, 2015, and March 24, 2016, and are within their expiration dates.
The recall covers all lots of the affected sucralfate products. These products were distributed in the United States, specifically in California, Hawaii, and New Mexico. 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.
Consumers and healthcare providers who have these products should stop using them and contact Reliable Drug or their healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- All sucralfate 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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