The Recall Desk
ModerateFDA (Drugs)·D-1111-2016·Announced 2016-07-13

Reliable Drug Recalls Compounded Retinoic Acid Products Due to Processing Controls

Reliable Drug is recalling all compounded retinoic acid products due to a lack of processing controls. The products were 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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The specific hazard is a lack of processing controls, which is a quality issue rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Reliable Drug/Reliable Compounding Pharmacy is recalling all retinoic acid products, which are prescription-only medications compounded by the firm. The recall is being conducted because of 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, specifically in 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 recalled product

Product
All retinoic acid 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 →