Reliable Drug Recalls Compounded Hydrocortisone Products Due to Processing Controls
Reliable Drug is recalling all compounded hydrocortisone products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The specific hazard of 'lack of processing controls' implies a risk of contamination or quality issues, but no specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Reliable Drug/Reliable Compounding Pharmacy is recalling all hydrocortisone 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 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.
The recalled product
- Product
- All hydrocortisone 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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