The Recall Desk
ModerateFDA (Drugs)·D-1125-2016·Announced 2016-07-13

Reliable Drug Recalls Compounded Estradiol Products Due to Processing Controls

Reliable Drug is recalling all compounded estradiol products due to a lack of processing controls. The recall covers lots compounded between March 2015 and March 2016.

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 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. No specific injuries or illnesses are reported in the source text.

Plain-English summary

Reliable Drug/Reliable Compounding Pharmacy is recalling all estradiol products, prescription only, compounded by the firm located 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 dates. These products were distributed in the United States, including 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 recall is classified as Class II by the FDA.

The recalled product

Product
All estradiol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

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

Distributed in 3 states:

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.

See all 70 products in this recall →