Reliable Drug Recalls Mirtazapine Products Due to Processing Control Deficiencies
Reliable Drug/Reliable Compounding Pharmacy is recalling all mirtazapine products compounded between March 24, 2015, and March 24, 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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Reliable Drug/Reliable Compounding Pharmacy, located in San Francisco, California, is recalling all mirtazapine products compounded by the facility. The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates. The products are prescription-only and were distributed in California, Hawaii, and New Mexico.
The recall was initiated due to a lack of processing controls. The source text does not specify the exact nature of the processing failure or report any illnesses or injuries associated with the use of these products.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- All mirtazapine 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
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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