Reliable Compounding Pharmacy Recalls Melatonin Products Due to Processing Controls
Reliable Compounding Pharmacy is recalling all compounded melatonin 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 due to a lack of processing controls, which is a quality issue that may lead to temporary or medically reversible adverse health consequences, fitting the Moderate severity criteria for minor labeling or quality errors without reported serious injury.
Plain-English summary
Reliable Rexall-A Compounding Pharmacy is recalling all compounded melatonin products, prescription only, manufactured by the company in San Francisco, California. The recall is being conducted due to a lack of processing controls. The affected products include all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration date.
The recalled products were distributed in the United States, specifically in California, Hawaii, and New Mexico. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased these products should stop using them and contact their pharmacist or the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- All melatonin 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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